CDSCO risk classification
Dental medical device classification
Every dental device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 130 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 240
- Class A
- 148
- Class B
- 67
- Class C
- 22
- Class D
- 0
Dental devices and their class
240 devices
3-D Oral Scanner (Intraoral Optical Scanning System, Diagnostic)
Dental
Class BA standalone device assembly intended to create 3-dimensional (3D) digital impressions of a patient's oral cavity, including the structure of teeth, gums and bite relationship, by optical scanning (visible/near infrared spectrum), for further design and manufacturing of dental restorations and prosthesis. It can additionally aid and screen for the oral conditions such as dental caries, etc.
3D Printing Dental Laboratory Model Resin
Dental
Class ANon-sterile, non-measuringA non-sterile photopolymer intended solely for use in dental laboratories for the fabrication of patient-specific 3D printed working models based on dental anatomical data. These models are used as physical references for the design and manufacturing of dental prostheses. The device is not intended for intraoral use or direct patient contact.
Abrasive polishing agent
Dental
Class ANon-sterile, non-measuringA substance, or combination of abrasive substances (e.g. silica pumice), intended to be used for cleaning the accessible surfaces of the teeth by polishing. It does not contain medication and used by dental professionals.
Bar dental precision attachment
Dental
Class AIt connect removable partial dentures to fixed bridgework under a male/female locking mechanism.
Bite block, dental, reusable
Dental
Class ANon-sterile, non-measuringA non-sterile device intended to be inserted into a patients mouth for the prevention of oral tissue damage (e.g., the teeth, lips, tongue and buccal mucosa) and to allow them to bite down on for greater comfort during a dental procedure. This is a reusable device.
Bite registration rim
Dental
Class BA schematic model of the dental arch attached to a temporary or permanent base for recording jaw relationships.
Bite registration rim wax
Dental
Class ANon-sterile, non-measuringA dental material (modelling wax) with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). This is a single-use device.
Bite registration rim wax, plate
Dental
Class BA dental material (modelling wax) delivered as prefabricated plates of wax with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims).
Bone matrix implant, human-derived
Dental
Class CA sterile implantable device made primarily of human demineralized bone matrix (DBM) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone.
Calcium hydroxide dental cement
Dental
Class BUse as a dental cement and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid.
Carboxymethylcellulose sodium denture adhesive
Dental
Class BAn adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth.
Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free
Dental
Class BAn adhesive compound intended to be used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth.
Ceramic artificial teeth
Dental
Class BPrefabricated teeth made of ceramic (porcelain) for mounting on removable dentures or fixed partial dentures.
Clamp for rubber dam
Dental
Class ANon-sterile, non-measuringA dental device intended to anchor a rubber dam down to the cervical region of an exposed tooth.
Collagen dental regeneration membrane
Dental
Class CA sterile, bio absorbable, animal-derived collagen (e.g., porcine) intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and/or to regenerate bone or bone defects around dental implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period.
Cottonoid pad, non-sterile
Dental
Class ANon-sterile, non-measuringA non-sterile absorbent device intended to absorb the saliva that is being secreted during dental procedures to maintain a dry field.
Dappen dish, reusable
Dental
Class ANon-sterile, non-measuringIt is a small bowls used to mix and hold dental materials. These dishes can be disposable or reusable
Dappen dish, single-use
Dental
Class ANon-sterile, non-measuringA small, shallow concave vessel used to knead and hold dental materials.
Dental abrasive disk guard
Dental
Class ANon-sterile, non-measuringA dental device intended to be fitted around an abrasive disk when rotating at high-speed to protect tissues not intended to come in contact with the abrasive disk.
Dental abrasive disk, reusable
Dental
Class ANon-sterile, non-measuringA non-sterile dental lab instrument intended for use in contouring, finishing, and polishing dental restorations. Not intended for direct patient contact.
Dental abrasive disk, single- use
Dental
Class ANon-sterile, non-measuringA non-sterile dental lab instrument intended for use in contouring, finishing, and polishing dental restorations. Not intended for direct patient contact.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Dental Abrasive Disk, single-use
Dental
Class BA dental instrument, which may carry or contain an abrasive, intended for use in connection with a dental power handpiece to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations (e.g., dentures, fillings, crowns). This is a single-use device.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Dental Abrasive Point, reusable
Dental
Class BAn intraoral instrument, containing an abrasive, intended for use in connection with a dental power handpiece to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations (e.g., dentures, fillings, crowns), polishing dental enamel for prophylaxis, tight margninal closure, etc. This is a reusable device.
Dental abrasive strip, reusable
Dental
Class ANon-sterile, non-measuringIt is intended to be used for cleanup, polish or finish dental crowns and bridges after cementation of crowns, veneers, bridges, inlays or onlays. Not intended for direct contact with tooth.
Dental abrasive strip, single- use
Dental
Class ANon-sterile, non-measuringIt is intended to be used for cleanup, polish or finish dental crowns and bridges after cementation of crowns, veneers, bridges, inlays or onlays. Not intended for direct contact with tooth.
Dental amalgam
Dental
Class BA dental restorative material used primarily to fill tooth cavities, prepared by mixing liquid mercury (Hg) with an alloy of fine particles, composed mainly of silver (Ag), tin (Sn) and copper (Cu).
Dental amalgam mercury dispenser
Dental
Class AA device with a valve intended to measure and dispense into a mixing capsule a predetermined amount of dental mercury in droplet form which is to be used to produce amalgam filling material.
Dental amalgam mixer
Dental
Class ANon-sterile, non-measuringThis is a dental benchtop device intended to mix by vibration/shaking, encapsulated materials to be used for dental restorative procedures in the mouth.
Dental anaesthesia injection kit
Dental
Class BA collection of sterile devices designed to inject dental anaesthetics into gingival tissue or the oral mucosa, while preventing or reducing the risk of accidental needle-stick injury, during restorative or surgical dental procedures.
Dental anaesthesia syringe cartridge
Dental
Class CA plastic or glass container prefilled with a single dose of anaesthetic medication intended to be inserted into a dental anaesthesia syringe and injected into oral tissues for a dental procedure.
Dental anaesthesia syringe, intraligamentary
Dental
Class CA hand-held manual dental instrument intended to be used to inject an anaesthetic agent under pressure via the periodontal ligament or into bone through an attached sterile needle. This is a reusable device.
Dental anaesthesia syringe, reusable
Dental
Class BA hand-held manual dental instrument intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle a needle is not included.
Dental anaesthesia syringe, single-use
Dental
Class BA sterile, hand-held, manual dental instrument intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle (needle not included).
Dental anaesthesia syringe/needle
Dental
Class BA hand-held manual dental instrument intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an included sterile needle the needle may be attached or detached.
Dental anaesthesia system
Dental
Class CAn assembly of devices used for the administration of a proportional mixture of oxygen (O2) and nitrous oxide (N2O) or medical air during dental surgical treatment.
Dental Anesthesia Injection Handpiece, Computer-Controlled
Dental
Class BA hand-held, microprocessor-controlled, dental device intended for use in conjunction with a dental needle [not included] and anesthetic vial [not included], to accurately administer a local anaesthetic agent within the oral cavity for improved analgesic localization and pain reduction. This is a reusable device intended to be sterilized/disinfected prior to use. This does not generate anesthetic agents.
Dental articulation liquid
Dental
Class ANon-sterile, non-measuringA range of pressure indicating material intended to locate areas of denture or removable dental device discomfort in the patients mouth for seating crowns, bridges, full dentures, immediate dentures and partial dentures.
Dental articulation paper
Dental
Class ANon-sterile, non-measuringIntended for marking areas of contact between opposite teeth, restorations or appliances.
Dental articulation paper forceps
Dental
Class ANon-sterile, non-measuringA hand-held manual dental instrument designed for grasping and holding articulation paper during its application to a patients oral cavity.
Dental automated x-ray film processor
Dental
Class ANon-sterile, non-measuringA mains electricity (AC-powered) automated dental x-ray film processor intended for the rapid processing of dental x-ray films.
Dental Bonding Agents
Dental
Class BA dental resin used in the bonding of light cured composites and acid modified composites to tooth structure.
Dental bone matrix implant, animal-derived
Dental
Class CA sterile bio absorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation.
Dental bone particle collector
Dental
Class BA device used to collect bone debris generated by drilling, etc. during oral surgery.
Dental camera cover, non- sterile
Dental
Class ANon-sterile, non-measuringA non-sterile device intended to provide an infection-control protective barrier for dental intra-oral camera.
Dental Caries Removal Solution
Dental
Class BA liquid substance used in dentistry to detect and remove caries from an infected tooth.
Dental Cements
Dental
Class BIntended for direct/indirect restoration (temporary/permanent) of tooth.
Dental cheek retractor, home-use
Dental
Class ANon-sterile, non-measuringThis is a hands-free, self-retaining frame that is intended for home use by a patient to retract the lips/cheeks to facilitate viewing of the teeth.
Dental cheek retractor, professional
Dental
Class ANon-sterile, non-measuringA non-sterile, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It may also be designed to displace the tongue. It is not intended to connect to an active device.
Dental Cleansing Solution
Dental
Class BA liquid used to clean cavities or root canals after preparation, and may also be used for disinfecting the cavity or root canal in endodontic procedures.
Dental collar/crown scissors
Dental
Class AScissors use to cut delicate tissue to removing sutures to performing precision procedures.
Dental Composite Resin Kit
Dental
Class BA collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application it does not include non-resin based cement nor dental prosthesis.
Dental cotton roll
Dental
Class AIt is intended as an absorbent, hard-packed cylinder (a roll) that is used as a saliva absorber from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure.
Dental cotton roll, non-sterile
Dental
Class ANon-sterile, non-measuringIt is intended as an absorbent, hard-packed cylinder (a roll) that is used as a saliva absorber from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. Not intended for long-term use.
Dental crown, metal/ceramic
Dental
Class BA device made of a combination of metal and tooth- coloured ceramic, that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.
Dental crown, metal/polymer
Dental
Class BA device made of metal, veneered with a polymer- based, tooth-coloured material, and created for a specific patient, that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.
Dental crown, polymer
Dental
Class BA device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific patient, that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.
Dental crown/bridge resin, temporary
Dental
Class BA material used to manufacture crowns and bridges.
Dental crown/bridge, temporary
Dental
Class BIntended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.
Dental Cryogenic Spray
Dental
Class ANon-sterile, non-measuringA cryogenic gas intended to be used in dentistry for the indirect cooling of a tooth by cooling a cotton pellet which is subsequently applied to the tooth to test pulp vitality. This is not intended for direct intraoral use. It is supplied non-sterile.
Dental cuspidor
Dental
Class ANon-sterile, non-measuringThis is a vessel, e.g. a round bow, into which the patient may expectorate during and after dental procedures.
Dental Delivery System, with Dental Chair
Dental
Class BA powered device assembly intended to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities include compressed air, water, suction, electricity, tabletop or bracket table surfaces, cuspidor, gas, suction/irrigation/aspiration handpieces (2-way or 3-way syringes) and/or dental examination light. It may incorporate an instrument unit for dental instrument provision. The patient examination/treatment chair is integrated as part of this system.
Dental dressing forceps, reusable
Dental
Class ANon-sterile, non-measuringA hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patients oral cavity.
Dental dressing forceps, single-use
Dental
Class AA sterile, hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patients oral cavity.
Dental elevator, sinus lift, reusable
Dental
Class ANon-sterile, non-measuringA hand-held, manual, dental surgical instrument intended to lift and displace sinus mucosa (Schneiderian membrane) from the maxillary sinus floor to allow for insertion of a bone graft during sinus lift surgery. This is a reusable device intended for transient use.
Dental elevator, tooth/root, reusable
Dental
Class ANon-sterile, non-measuringA hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. This is a reusable device intended for transient use.
Dental endodontic enlarger
Dental
Class BA device for enlarging and preparing the root canal, which probes, enlarges, and cleans the root canal by dental file, etc. The motion of the file includes vibrating, rotating, repeating rotation, reciprocating, and a combination of these motions.
Dental Etchant
Dental
Class BThe material is applied for temporary etching of dental hard tissue in order to condition the surface for bonding procedures.
Dental examination kit
Dental
Class AIntended as a kits for dental examination.
Dental examination kit, reusable
Dental
Class ANon-sterile, non-measuringA collection of non-sterile dental instruments (forceps, mirror, probe, spatula, excavator) intended to be used to perform general dental examination. It is not intended for surgical procedures. Kit does not contain any dental implants, medicines/substances or fill materials. This device is reusable intended to be sterilized prior to use.
Dental excavator, reusable
Dental
Class ANon-sterile, non-measuringIt is a device intended to cutting, clean out and shape a carious cavity before filling it.
Dental excavator, single-use
Dental
Class AIt is a single use device intended to cutting, clean out and shape a carious cavity before filling it.
Dental float/rasp, manual (for veterinary use)
Dental
Class ANon-sterile, non-measuringIntended for periodic grinding of teeth of animals with continuously growing teeth, such as cattle and horses, in order to aid in proper chewing and prevent injury to cheeks and oral cavity.
Dental floss
Dental
Class ANon-sterile, non-measuringIt is a tape/thread-like device intended for removing plaque, tartar, etc. from between the teeth and aid in prevention of dental caries.
Dental handpiece cover, non-sterile
Dental
Class ANon-sterile, non-measuringA non-sterile device intended to cover and protect a dental handpiece during dental procedures and prevent cross-infection between patients.
Dental implant
Dental
Class CA dental implant is a surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis such as crown, bridge, denture, facial prosthesis or to act as an orthodontic anchor.
Dental implant abutment analog, laboratory
Dental
Class ANon-sterile, non-measuringA rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.
Dental implant abutment impression cap
Dental
Class ANon-sterile, non-measuringA device intended to be placed intraorally on the abutment head of a dental implant during dental impression procedures, to facilitate the removal of the impression material after setting and to ensure the position of the implant in order to transfer it to a working model for the dental technician.
Dental implant abutment trial
Dental
Class ANon-sterile, non-measuringA copy of a dental implant abutment intended to be used intraorally during dental implant restorative procedures to reproduce the characteristics of an abutment (e.g., angle, diameter, transmucosal or cementable area height) to facilitate selection of an appropriate final prosthetic abutment. This is not a dental implant. This is a reusable device.
Dental implant extractor, reusable
Dental
Class ANon-sterile, non-measuringThis is a manually-operated, dental device that is intended to be used to retrieve a dental implanted device, typically because of damage (e.g., a broken collar) or malfunction, from the oral cavity. This is a reusable device.
Dental implant/prosthesis handling forceps, reusable
Dental
Class ANon-sterile, non-measuringThis is a hand-held manual dental instrument intended for grasping and holding a dental devices(e.g., crown, bridge, screw) during its application to a patients oral cavity. This is a reusable device.
Dental impression adhesive
Dental
Class ANon-sterile, non-measuringA liquid material specifically intended to give adhesion of an impression material to the impression tray.
Dental impression material
Dental
Class ANon-sterile, non-measuringThis material is primarily used to take an oral impression.
Dental impression material kit, reusable
Dental
Class ANon-sterile, non-measuringDevices and materials used to take the impression.
Dental impression material kit, single-use
Dental
Class ANon-sterile, non-measuringA collection of non-sterile devices designed to obtain a negative imprint of the teeth. The kit typically includes dental impression materials and a dental impression tray(s); This is a single-use device.
Class taken from Merged existing medical devices risk classification, entry Dental 18, because the register feed omits it.
Dental impression material mixer
Dental
Class ANon-sterile, non-measuringAn electric device used to mix impression materials immediately before use at the chair side.
Dental impression material syringe
Dental
Class ANon-sterile, non-measuringThis dental injection syringe is used to inject the impression material onto the impression tray.
Dental impression spacer
Dental
Class ANon-sterile, non-measuringA device intended to be temporarily applied to the surface of edentulous ridges and dental structures before the preliminary application of impression material. This is a non-sterile, single- use device.
Dental impression tray material
Dental
Class AA material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The material is used in cases in which a preformed impression tray is not suitable.
Class taken from Merged existing medical devices risk classification, entry Dental 21, because the register feed omits it.
Dental impression tray, reusable
Dental
Class ANon-sterile, non-measuringA impression tray is a metal or plastic device intended to hold impression material, to make an impression of a patients teeth to reproduce the structure of a patients teeth.
Dental impression tray, single-use
Dental
Class AThe device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.
Dental irrigation/aspiration syringe, reusable
Dental
Class ANon-sterile, non-measuringA hand-held manual dental device (a plunger- type syringe) intended to inject and/or aspirate a volume of solution into the working area in the oral cavity. This is a reusable device.
Dental laboratory bur, reusable
Dental
Class ANon-sterile, non-measuringA rotary cutting device intended to fit into a dental laboratory handpiece that provides the rotation for dental laboratory use only to cut hard structures (e.g., metals, plastics, porcelains), during the fabrication of dental restorations. This is not intended for in-patient use.
Dental laboratory curing light
Dental
Class ANon-sterile, non-measuringAn electrically-powered device intended to be used in the dental laboratory for curing polymer- based materials. This can be achieved by heat, heat and pressure, light, or a combination of these. It is not a measuring device.
Dental material application tool, reusable
Dental
Class ANon-sterile, non-measuringIntended to be used in dentistry for the application of a dental material (e.g., composite resin, etchants, etc.) to a dental prosthesis or to a patient’s tooth/teeth or elsewhere in the oral cavity.
Dental material heater
Dental
Class ANon-sterile, non-measuringIntended to heat regular (paste) and flowable composite material, including bulk fill composites, compules, porcelain veneers and onlays.
Dental material mixing nozzle, non-sterile
Dental
Class ANon-sterile, non-measuringA device intended for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material (not included) which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application.
Dental material mixing surface, reusable
Dental
Class ANon-sterile, non-measuringA dental instrument slab or tray used as a surface to mix dental materials.
Dental material mixing surface, single-use
Dental
Class ANon-sterile, non-measuringIt has pad or tray used to knead or mix dental material (impression material, cement, etc).
Dental matrix band, reusable
Dental
Class ANon-sterile, non-measuringA dental instrument intended to contour a dental restorative material to match dentition within the oral cavity. This is not a dental implant.
Dental matrix band, single- use, non-sterile
Dental
Class ANon-sterile, non-measuringA dental instrument intended to contour a dental restorative material to match dentition within the oral cavity. This is a non-sterile, single-use device. This is not a dental implant.
Dental matrix wedge
Dental
Class ANon-sterile, non-measuringIntended for use as a wedge between teeth to create space when applying restorative materials.
Dental Mirror, reusable
Dental
Class ANon-sterile, non-measuringA hand-held, dental instrument, consisting of a shaft/handle and an angled mirror, intended to be used by a dentist for intraoral inspection and retraction. This is a transient-use, reusable device and supplied non-sterile.
Dental needles
Dental
Class BDental needles are used to deliver local anaesthetic to the operative site in order to make a patient as comfortable as possible.
Dental Occlusal Splint, removable
Dental
Class ANon-sterile, non-measuringA non-powered, non-sterile, removable dental device intended for the protection of teeth and dental restorations from the forces and damage of parafunctions like bruxism (teeth grinding and clenching), prevention of noise associated with bruxism, and for the alleviation of tension and pain in the temporomandibular joint, jaw, and surrounding muscles associated with Temporomandibular Disorders (TMD). This is not a dental implant. This is a single-patient, reusable device.
Dental polishing brush
Dental
Class AA rotary dental brush intended for cleaning and polishing by a dental hygienist or a dentist.
Dental Power Motor with Apex Locator
Dental
Class BA powered dental device intended for use by qualified dental professionals during endodontic procedures to mechanically drive endodontic files and to determine the working length of the root canal by electronically locating the apical foramen.
Dental precision attachment fitting/adjustment tool, reusable
Dental
Class ANon-sterile, non-measuringThis is a hand held, manual dental laboratory instrument that is intended to be used in a dental laboratory or dental surgery during fabrication or revision of a final dental prosthesis (e.g., denture, crown, bridge) to integrate and/or adjust the fitting between male and female precision attachments. This is a reusable device.
Dental Prosthesis Priming Agent
Dental
Class BA material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) immediately prior to insertion into a tooth structure to promote bonding to a prosthesis component during a dental procedure in the mouth.
Dental prosthesis/implant abutment screw analog, reusable/ Guide pin, reusable
Dental
Class ANon-sterile, non-measuringA device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. It is not a dental implant.
Dental resin applicator
Dental
Class ANon-sterile, non-measuringIntended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth the restorative material is not included.
Dental Resin Polymerization Light/Lamp
Dental
Class BA hand-held, powered device intended to activate the polymerization of a dental resin-based material in the oral cavity by irradiation with LED light in visible/UV spectrum. This may also be used to detect caries/dental calculus using fluorescence under violet light. This does not emit ionizing radiation. This is a reusable device.
Dental Resin, Burnout Casting
Dental
Class ANon-sterile, non-measuringA photocurable resin intended solely for dental laboratory use for 3-D printing of burnout objects (burnout models) based on patient anatomy during manufacturing of dental prostheses, such as partial dentures, crowns and bridges, inlays, onlays and veneers. It is completely burned out in the investment material prior to casting and does not come in contact with the patient. This is not a dental resin material or intended to fabricate dental prostheses/implants.
Dental rongeur, reusable
Dental
Class ANon-sterile, non-measuringA hand-held, manual instrument intended to be used in dental surgery to remove hard or tough body tissues such as cartilage or bone, by applying a biting/cutting action. This is a reusable device intended for transient use.
Dental Root Surface Conditioner
Dental
Class BAssists in the debridement and cleaning of root canals (dental) Aids in the chemical breakdown of pulp soft tissue (dental).
Dental Rotary Bur
Dental
Class BA rotary device intended for use by dentists in connection with a dental handpiece for cutting, slicing, drilling, and other operations on hard structures such as teeth and restorations in the oral cavity. The working part may be coated with carbide, diamond particles, or other biocompatible metal.
Dental rubber dam clamp forceps, reusable
Dental
Class ANon-sterile, non-measuringA hand-held dental instrument intended for the insertion and removal of rubber dam clamps. This is a reusable device.
Dental rubber dam, non- sterile
Dental
Class ANon-sterile, non-measuringA non-sterile dental device intended to be placed over the teeth during dental procedures for uses such as 1) to isolate the field of operation from the rest of the oral cavity 2) to eliminate saliva 3) to prevent the patient swallowing liquid/dental material 4) to protect soft tissue from harmful solutions and 5) to reduce risk of infection.
Dental Scan Post Organizer Box, reusable
Dental
Class ANon-sterile, non-measuringAn empty container intended for holding and organizing dental scan posts. This is a reusable device.
Dental soft-tissue coring punch, reusable
Dental
Class ANon-sterile, non-measuringA manual dental instrument intended to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. This is a reusable device.
Dental soft-tissue matrix implant, animal-derived
Dental
Class CA sterile, bio absorbable, animal-derived collagen (e.g., porcine) intended to be used to aid in the regeneration of oral soft tissue, lost due to periodontal disease or trauma, through promotion of new blood vessels and/or by providing a temporary scaffold for tissue ingrowth it is indicated for various oral soft tissue augmentation procedures (e.g., alveolar ridge reconstruction, localized gingival augmentation, covering of recession defects and extraction sockets). It is a pliable material which may be fixed to soft tissues with sutures it is applied to soft tissue during periodontal flap surgery and guided tissue regeneration (GTR) surgical procedures. This is a single-use device.
Dental spatula
Dental
Class ANon-sterile, non-measuringA hand-held, manual device intended for kneading or mixing dental material (impression material, cement, etc). This may be reusable or single-use.
Dental spatula, reusable
Dental
Class AA dental instrument used to mix dental materials. Some are equipped with an injection function.
Dental spatula, single- use
Dental
Class AA spatula-shaped device used to knead or mix dental material (impression material, cement, etc).
Dental suction protective mouthpiece
Dental
Class ANon-sterile, non-measuringA prefabricated device intended to be placed in the oral cavity during a dental procedure to protect the oral pathway by serving as a conduit for the continuous suction of debris/saliva, shielding the oral anatomy, maintaining an open mouth and retracted cheeks, and depressing the tongue.
Dental suction system
Dental
Class BIt evacuate solids, liquids, aerosols and gases from the oral cavity and immediate surrounding area for the purpose of improving operating effectiveness and efficiency during oral treatment procedures and limiting the contamination of the immediate environment.
Dental suction system cannula, reusable
Dental
Class AA tubal dental device to be connected to a non-active aspiration device (usually, a dentistry dedicated device). Used to eliminate water and cutting debris that have accumulated in the oral cavity. This device is reusable after sterilization.
Dental suction system cannula, single-use
Dental
Class AA tubal dental device to be connected to a non-active aspiration device (usually, a dentistry dedicated device). Used to eliminate water and cutting debris that have accumulated in the oral cavity.
Dental suction system disinfection control unit
Dental
Class BAn electrically-powered device intended to control the regular (typically daily) automated/semi-automated disinfection of a dental suction system tubing line.
Dental suction system fluid-separation unit
Dental
Class ANon-sterile, non-measuringA separator used in the oral cavity. Used for the separation of fluids (saliva, blood) from gases to avoid liquids from entering the suction pump (i.e., dry suction).
Dental suction system pump
Dental
Class BAn electrically-powered dental suction pump used as the suction source of a dental suction system, dental treatment unit, etc.
Dental Surgical Implantation Template
Dental
Class ANon-sterile, non-measuringA custom-made, non-invasive device intended for use by dental surgeons to assist in guiding drilling in the patient jawbone during the first stage of a guided dental implantation procedure and subsequently assisting in the placement of dental implants. This is designed based on 3-D patient anatomy models and intended for single-use.
Dental surgical microscope
Dental
Class ANon-sterile, non-measuringThis is a dental device that is intended to magnify and visualize minute intraoral structures during dental examination and dental surgical procedures in the mouth.
Dental Surgical Motor
Dental
Class BAn electrically-powered device intended to accept an endpiece(s) [e.g., drill bit, saw blade] and provide a controlled torque for drilling, cutting, polishing, placing implants and/or inserting procedures involving bones and tough tissues during a dental surgical procedure.
Dental surgical probe, reusable
Dental
Class ANon-sterile, non-measuringA hand-held manual dental surgical instrument intended to be used to explore and/or perform therapeutic procedures during various types of dental surgical intervention. This is a non- measuring, reusable device.
Dental surgical procedure kit, medicated, reusable
Dental
Class CA collection of various dental instruments, dressings, pharmaceuticals and the necessary materials used to perform a dental surgical procedure.
Dental surgical procedure kit, medicated, single-use
Dental
Class CA collection of various sterile dental instruments, dressings, pharmaceuticals and the necessary materials used to perform a dental surgical procedure.
Dental torque wrench adaptor
Dental
Class ANon-sterile, non-measuringIt is intended to enable connection of the main body of the wrench to a specific endpiece(s). It is intended for transient use.
Dental Varnishes/ Glazing
Dental
Class BA dental device intended to be applied to the surface of a restorative dental filling to attain a smooth, glaze- like finish on the surface.
Dental Water Distillation Unit
Dental
Class ANon-sterile, non-measuringA powered device intended to distill (demineralize) water using heat and condensation for supplying to dental equipment, including dental autoclaves, dental chair water bottles, ultrasonic scalers, mixing dental materials, etc., to aid in prevention of mineral scaling, corrosion, and microbial growth, and supporting infection control in dental equipment.
Dental wedge (for veterinary use)
Dental
Class ANon-sterile, non-measuringIntended for use during dental examination/treatment to retract soft tissues from teeth, isolate a teeth for treatment/examination purposes, etc.. This is a reusable device.
Dental X-ray beam aligner
Dental
Class ANon-sterile, non-measuringIntended to assist the dental radiographer to align the positioning indicator device relative to the tooth and receptor.
Dental X-ray film holder
Dental
Class ANon-sterile, non-measuringIt is used to hold the dental X-ray films and position it to the right angle inside the mouth to aim taking an accurate X-ray.
Dental-professional prophylaxis brush/Dental polishing brush
Dental
Class ANon-sterile, non-measuringA rotary dental instrument intended to be used by a dental hygienist and/or dentist to clean and polish teeth.
Dental/oral lavage unit (water flosser)
Dental
Class ANon-sterile, non-measuringIntended to inject a stream of water on teeth to remove dental plaque in between teeth and improve gum health. It is intended as an OTC (home use) device.
Dentifrice/ Dental polishing paste
Dental
Class ANon-sterile, non-measuringProphylaxis pastes without fluoride intended to be used by professionals for tooth cleaning and polishing procedure by abrasion/mechanical cleaning only.
Dentin Processing Device
Dental
Class BAn electrically powered device that grinds patients own tooth into into collagen-rich granules and process it with the help of kit/ cartridge for automatic preparation of autologous bone graft material for use for various bone regeneration applications.
Denture Base Resin
Dental
Class BA collection of resins and other devices and/or materials intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth).
Dentures cup
Dental
Class ANon-sterile, non-measuringThis cup is intended to hold patient dentures when they are not in the mouth.
Electric dental chair without operative unit
Dental
Class ANon-sterile, non-measuringA mains electricity (AC-powered) device intended to support a patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It does not include operative unit.
Electric Dental Pulp Testing Device
Dental
Class BA powered, dental device intended for use by trained healthcare professionals to test dental pulp vitality by applying electric current to tooth surface and measuring neural response, thereby aiding in diagnosis of dental pulp conditions.
Electric toothbrush
Dental
Class ANon-sterile, non-measuringIntended to remove plaque, tartar, etc. from teeth and gums and aid in prevention of dental caries, etc.
Electrognathography Jaw Monitoring System
Dental
Class BA collection of devices, including a magnetic sensor array, non-invasive recording unit and software programs, intended to track, monitor, record and calculate various parameters associated with jaw motion (incisor point movements, variability, velocity, smoothness, etc.) as an aid in diagnosis and screening of jaw-related disorders. It may also be used for therapy monitoring, assessment of chronic jaw/dental pain, pre- and post-surgery examinations, etc.
Endodontic Apex Locator
Dental
Class BA dental instrument intended to be used by qualified dental professionals to electronically determine the position of the apical foramen and estimate the working length of the root canal during endodontic procedures. This is a reusable device.
Endodontic Gutta Percha Filling Device
Dental
Class BA hand-held, powered, dental endodontic device intended to heat (extrude), and backfill and down pack gutta-percha into prepared root canals for effective sealing (obturation).
Endodontic Obturation Cutter (Gutta Percha Cutter)
Dental
Class BAn electrically-powered, hand-held device intended to cut excess gutta percha pins inserted into the root canal of a tooth during the down-pack phase of root canal filling. It may in addition provide the heat necessary to condense the gutta percha to seal the root canal.
Endodontic plugger, reusable
Dental
Class ANon-sterile, non-measuringA hand-held, manually-operated, dental instrument specifically intended to compress filling materials in a root canal, mainly in an axial direction. This is a reusable device.
Endodontic Sealer
Dental
Class BTo fill and seal all pathways between the root canal and external surfaces of the tooth i.e., for permanent obturation of the root canal. Intended for use in procedure involving root filling, repair of root perforations, pulp capping and apexification.
Endosseous dental implant
Dental
Class CIntended to be surgically placed in the bone of jaw arches to provide support for prosthetic devices, such as artificial teeth.
Endosseous dental implant abutment
Dental
Class CIntended for use as an aid in prosthetic rehabilitation.
Filter for dental suction equipment
Dental
Class ANon-sterile, non-measuringIntended to be fitted in the suction line of a dental suction system (e.g., in the saliva ejector valve) to trap debris [e.g., amalgam, bone particles, dentin/enamel particles] and stop them from entering the mains drainage system during a dental procedure. This is not an autologous bone collector. This is a reusable device
Fixed Denture
Dental
Class CA custom-made, non-removable, dental prosthesis comprising of a denture base and artificial teeth supported by a metal framework to replace natural teeth and gingiva in partially or fully edentulous patients for the purpose of restoring the function of chewing. It is fixed to abutments, tooth roots, and/or dental implants by a trained dental professional and cannot be removed without medical intervention.
Forceps, dental, reusable
Dental
Class ANon-sterile, non-measuringA reusable hand-held dental instrument used in the mouth for gripping applications.
Forceps, Tooth extraction, reusable
Dental
Class ANon-sterile, non-measuringA hand-held manual dental surgical instrument intended for the extraction of teeth. This is a reusable device.
Gingival barrier (non- medicated)
Dental
Class ANon-sterile, non-measuringIntended for protection of gingival area during tooth bleaching process.
Gingival Bleaching Protector
Dental
Class BA non-sterile paste or gel-like substance designed to protect a patients gums from the hydrogen peroxide (H2O2) found in teeth whitening agents used during chairside light-curing bleaching of the teeth.
Hand-held dental retractor, reusable
Dental
Class ANon-sterile, non-measuringA hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. This is a reusable device.
Hoof knife
Dental
Class ANon-sterile, non-measuringA non-powered device intended to cut the hooves in animals such as cattle for purposes such as preventing mobility issues, and aiding in examination/treatment by a veterinarian, etc.
Hoof trimmer/puller
Dental
Class ANon-sterile, non-measuringA non-powered device intended to pull or trim the hooves of animals such as horses to aid a veterinarian during medical examination/treatment.
Intraoral camera
Dental
Class ANon-sterile, non-measuringIntended to capture high resolution image/video of intraoral anatomy as an assistive aid during management of dental/intraoral conditions (e.g., plaque, tartar, etc.) using light in visible/infrared spectrum only. It is not intended for diagnostic purposes and cannot connect to other high-risk active devices. This is a reusable device.
Intraoral Optical Scanning System, basic OR 3D Oral Scanner
Dental
Class ANon-sterile, non-measuringA standalone device intended to create 3- dimensional (3D) digital impressions of a patients oral cavity, including the structure of teeth and gums, by optical scanning (laser/LED in visible/near infrared spectrum), which may be further used for design and manufacturing of dental restorations and prosthesis. It does not have any additional features/intended purposes, and cannot connect to any high-risk active device. This does not have a diagnostic or measuring function.
Intraoral-scanning analog for dental implant abutment
Dental
Class not statedA non-sterile intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is not a permanent implant.
The class is missing from CDSCO's register data for this entry. Check the CDSCO register before relying on it.
Irrigating Syringes
Dental
Class Bcleaning debris away from the area the dentist is working on
Irrigation tip, surgical mist
Dental
Class ANon-sterile, non-measuringA non-sterile device that is intended to be connected to an air/water syringe to blow a mixture of air and/or water into a patients mouth to clear debris during dental procedures.
Jaw Physiology Evaluation System, vibration analysis
Dental
Class BAn assembly of powered devices intended to record parameters for mandibular and muscles of mastication function, to aid in the diagnosis and therapy monitoring of temporomandibular joint (TMJ) and myofascial pain dysfunction (MPD) disorders, and for orthodontic, denture, and reconstruction patient evaluation. It uses sonography and/or other computer-based system to detect sounds/vibrations from the TMJ joint and/or non-invasively track the mandible in function or identify its position in space relative to the skull.
Kit/Cartridge for Tooth Processing System
Dental
Class ANon-sterile, non-measuringA collection of non-invasive, non-powered equipment and consumables intended for use with a tooth-processing system [not included] to aid in the controlled demineralisation, processing and collection of extracted human dentine for autologous bone grafting applications. This is a single-use device. It does not contain any sterilant or high-level disinfectant.
Ligature Wire
Dental
Class Boffer a spot-welded auxiliary hook which may be added to any bracket by simply tying in the arch wire
Manual dental burnisher, reusable
Dental
Class ANon-sterile, non-measuringIntended to polish the surface and smooth the margins of restorations during dental procedures.
Manual Endodontic File, reusable
Dental
Class ANon-sterile, non-measuringA hand-held, manual dental instrument intended for use by qualified dental personnel to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action. This does not connect to any high-risk, active devices and it does not have a measuring function. It may also be referred to as an endodontic rasp or reamer. This is a reusable device intended to be sterilized prior to use.
Manual endodontic filling material spreader
Dental
Class ANon-sterile, non-measuringA hand-held, manually-operated dental instrument specifically intended to compress filling materials in a root canal, mainly in a lateral direction. This is a reusable device.
Manual non-rotary dental instrument handle
Dental
Class ANon-sterile, non-measuringA hand-held, manual device intended to hold and facilitate manipulation of a non-powered, non- rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is intended to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device.
Manual toothbrush
Dental
Class ANon-sterile, non-measuringAn instrument intended to be used by a patient to manually brush clean their teeth and gums for removing plaque, tartar, etc. and/or aid in prevention of dental disorders such as caries.
Marker, dental use
Dental
Class ANon-sterile, non-measuringThis device range helps mark plaque areas on a tooth and is thus intended to be used to aid disclose/make marks that allows identify dental plaque.
Mechanical dental chair without operative unit
Dental
Class ANon-sterile, non-measuringIntended to support a patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It does not include operative unit.
Membrane fixation tack, bio absorbable
Dental
Class CA sterile bio absorbable tack intended to be used to fix a pliable-polymer dental regeneration membrane in situ to aid in the regeneration of tooth support that has been lost due to periodontal disease or trauma.
Mouth gag
Dental
Class ANon-sterile, non-measuringTo be used in dentistry to be placed between the teeth of a patient in order to maintain an open oral cavity during dental procedures.
Mouth speculum/ Mouth gag (for veterinary use)
Dental
Class ANon-sterile, non-measuringIntended to keep the mouth open during oral examination, intubation, etc. This is a reusable device.
Oral care swab
Dental
Class ANon-sterile, non-measuringA foam-headed oral swab impregnated with a sodium bicarbonate cleaning solution intended to be used wet to clean the teeth and oral cavity.
Oral Cavity Abrasive Polishing Agent
Dental
Class AAn oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth.
Orthodontic Adhesive
Dental
Class BUsed as a combined etchant and primer in orthodontic treatment used with/without light curing direct bonding orthodontic adhesive.
Orthodontic aligner/retainer seater
Dental
Class ANon-sterile, non-measuringA non-sterile device intended to aid in positioning and seating an orthodontic progressive aligner or teeth retainer into place. This is a reusable device intended for single-patient use.
Orthodontic appliance, Band
Dental
Class BDevice for fixed orthodontic appliances. Device affixed to contour of tooth/teeth and cemented into place to support (pressure can be exerted on the teeth) orthodontic appliances or attachments.
Orthodontic band pusher
Dental
Class ANon-sterile, non-measuringA hand-held dental instrument intended for positioning and adapting metal bands on teeth in orthodontics.
Orthodontic Elastomeric
Dental
Class AA tooth positioner/instrument intended to control settling/position and to minimize or eliminate relapse of the teeth after an orthodontic treatment.
Orthodontic elastomeric appliance pusher
Dental
Class ANon-sterile, non-measuringA hand-held device intended to be used by laypersons to remove/apply orthodontic elastomeric appliances (e.g., inter-arch bands, inter-bracket chains) from/to orthodontic brackets. This is a reusable device. This is not an implantable device.
Orthodontic Guide Wire
Dental
Class BA wire conforming to the alveolar or dental arch that can be used with dental braces as a source of force in correcting irregularities in the position of the teeth.
Orthodontic metal band pusher
Dental
Class ANon-sterile, non-measuringA hand-held dental instrument intended to be used by an orthodontist for positioning and adapting orthodontic metal bands on teeth. This is a reusable device. This is not an implantable device.
Orthodontic positioner support kit
Dental
Class ANon-sterile, non-measuringA collection of devices intended to be used to facilitate use of an orthodontic teeth positioner, including placement, removal and cleaning. It typically consists of an orthodontic appliance remover, an orthodontic positioner seater, and an orthodontic appliance cleanser. The positioner is not included. This does not contain dental implants/medicated products.
Orthodontic resin positioning tray
Dental
Class ANon-sterile, non-measuringA custom-made dental device in the form of a patient’s dentition which contains cavities intended to hold and facilitate positioning of light- cured dental resin onto teeth for subsequent attachment of an orthodontic appliance (e.g. aligner) after curing.
Orthodontic Tube
Dental
Class BAn orthodontic small metal part welded on the outside of a molar bank, which contains slots to holdarchwires, lip bumpers, facebows and other devices used to move the teeth.
Orthodontic vibrator
Dental
Class ANon-sterile, non-measuringOrthodontic predictability enhancement device intended to maximise the accuracy of fit and effectiveness of clear aligner treatment.
Orthopaedic dental file
Dental
Class BA hand-held dental surgical instrument used to enlarge the root canal, smooth out the root canal wall or shaping canals after they are previously cleaned by scratching/scraping with vertical reciprocating motion or rotary motion or plucking motion.
Overdenture
Dental
Class BA custom-made, removable (by the patient), dental prosthetic device intended to be applied in the mandible or maxilla of partially or fully edentulous patients and retained in the mouth using precision dental attachments connected to natural tooth roots, remaining teeth, or dental implants to restore chewing function. This is not a permanent implant.
Packer, gauze
Dental
Class ANon-sterile, non-measuringTo be used in dentistry and dental surgery for introducing and packing gauze or dressings into cavities.
Paediatric dental chair, electric without operative unit
Dental
Class ANon-sterile, non-measuringA powered, adjustable device solely intended to support a paediatric patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. Dental examination/treatment devices are not included.
Paediatric dental chair, mechanical without operative unit
Dental
Class ANon-sterile, non-measuringA manually- or hydraulically-powered, adjustable device solely intended to support a paediatric patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. Dental examination/treatment devices are not included.
Periodontal curette, reusable
Dental
Class not statedA hand-held dental instrument intended to be used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. This is a reusable device.
The class is missing from CDSCO's register data for this entry. Check the CDSCO register before relying on it.
Periodontal knife/Gingivectomy knife, reusable
Dental
Class ANon-sterile, non-measuringA hand-held dental instrument intended to excise the gums and other oral soft tissue during a periodontal intervention (e.g., a gingivectomy involving the excising of the soft tissue wall of a pocket). This is a reusable device intended for transient use.
Periodontal root surface regeneration material
Dental
Class CA bio absorbable material intended to be used alone or in combination with bone graft materials for the regeneration of tooth support that has been lost due to periodontal disease or trauma. It is applied during periodontal flap surgery to the scaled and preconditioned root surface and forms an insoluble matrix that creates a suitable root surface for selective periodontal cell migration and cell attachment, which re-establishes the lost tooth support.
Periodontal tissue reconstructive material
Dental
Class CA sterile viscous material intended to be injected into the buccal mucosa to treat deficiencies of the gingiva (e.g., interdental papillae), through augmentation, during the treatment of intermediate stage periodontal disease.
Periodontic hoe, reusable
Dental
Class ANon-sterile, non-measuringA hand-held manual dental instrument intended to be used with a pulling action to remove gross amounts of supragingival calculus, and some subgingival calculus, in large wide-open pockets where the gingival tissue is soft and easily cleaned. This is a reusable device.
Periotome, reusable
Dental
Class ANon-sterile, non-measuringA hand-held dental instrument intended to be used during tooth extraction/luxation to cut the periodontal ligament that binds the tooth to the surrounding marginal and alveolar bone (alveolar process), causing minimal mechanical trauma to the bone tissue. This is a reusable device intended for transient use.
Pliable-polymer dental regeneration membrane, bio absorbable, ligated
Dental
Class CA sterile bio absorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period.
Pliable-polymer dental regeneration membrane, bio absorbable, tacked
Dental
Class CA sterile bio absorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period.
Polymer Based Prosthodontic Material
Dental
Class BLight cured, methacrylate-based resin for creating reservoir space for bleaching trays is useful for laboratory procedures such as model, and die repair. It can be block out defects and under cuts on the stone models quickly and securely for precise abutment preparation.
Powered Surgical Drill Hand piece for Dental applications
Dental
Class BA device that consists of a hand piece to which is connected a variety of attachments in order to achieve a number of cutting/inserting/trimming operations.
Preformed dental crown, permanent
Dental
Class BA prefabricated prosthetic device designed to function as a permanent artificial covering to partially or fully replace the damaged crown of a tooth. It is available as a single prosthesis or multiple prostheses of various shapes and sizes, and may include one or more try-in prosthesis replicas and other devices intended to assist the restoration procedure.
Preformed dental crown, temporary
Dental
Class BThis device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury.
Removable Orthodontic Retainer
Dental
Class ANon-sterile, non-measuringA removable orthodontic appliance (or a series) intended to maintain and prevent movement of a patient’s dentition following corrective procedure. This is a single-patient, short-term use device.
Restorative Material
Dental
Class BA dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material for restoration of cavities in teeth.
Reverse-image mirror, dental
Dental
Class ANon-sterile, non-measuringA device intended to be placed at the back of the teeth while taking image for dental examination purposes.
Root Canal Filling removal Solution
Dental
Class BA liquid substance used in endodontic procedures for the softening and removal of root canal fillings. It will typically be introduced into the root canal using instruments. The device typically contains solvents and other elements (e.g., tetrachloroethylene, formamide, eucalyptol, excipients).
Rubber dam clamp forceps
Dental
Class AA hand-held dental instrument used for the insertion and removal of rubber dam clamps.
Rubber dam frame
Dental
Class ANon-sterile, non-measuringA flexible border intended to hold a rubber dam in a stretched state to improve access to the field of operation. This is a reusable device.
Rubber dam punch
Dental
Class ANon-sterile, non-measuringA hand-held dental instrument intended to place holes in rubber dam material to permit the passage of the dam over the crowns of the teeth. This is a reusable device.
Rubber dam, Natural rubber latex
Dental
Class not statedA dental device made of Hevea natural rubber latex (NRL) that is punched with holes and placed over the teeth during dental procedures for uses such as 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva
The class is missing from CDSCO's register data for this entry. Check the CDSCO register before relying on it.
Rubber dam, non-latex
Dental
Class ANon-sterile, non-measuringA dental device made of elastomeric synthetic material (e.g., silicone) that is punched with holes and placed over the teeth during dental procedure for uses such as: 1) to isolate the field of operation from the rest of the oral cavity 2) to eliminate saliva 3) to prevent the patient swallowing liquid/dental material 4) to protect soft tissue from harmful solutions and 5) to reduce risk of infection.
Scissors, dental, collar/crown, reusable
Dental
Class ANon-sterile, non-measuringA hand-held dental instrument intended to cut dental metal bands. This is a reusable device.
Scissors, dental, surgical tissue/ Dental surgical scissors, reusable
Dental
Class ANon-sterile, non-measuringA hand-held dental instrument intended to cut oral tissue during a dental surgical procedure. This is a reusable device for transient use.
Soft dental reliner
Dental
Class ANon-sterile, non-measuringIntended to be used as a tissue conditioner and a reliner for short term use for removable dentures. It may be intended for professional and/or home use.
Spring-loaded dental mallet, reusable
Dental
Class ANon-sterile, non-measuringA hand-operated spring-loaded device with variable power intended to be used to condense gold (Au) foil or seating dental inlays. This is a reusable device.
Surgical torque wrench adaptor, reusable
Dental
Class ANon-sterile, non-measuringThis is a hand-held component of a surgical wrench that is intended to connect the main body of the wrench to a variety of distal end pieces (bits) and assist with the use of a torque wench in the mouth during a dental procedure. This does not have a measuring function.
Teeth whitening tray
Dental
Class ANon-sterile, non-measuringA removable intraoral device intended to hold a dental bleaching agent (e.g., whitening gel) in close contact with the surfaces of natural teeth for treating dark and discolored teeth. This does not contain the bleaching agent.
Temporary mandibular condyle prosthesis
Dental
Class CA sterile implantable device intended for the temporary reconstruction of the mandibular condyle of the temporomandibular joint (TMJ) typically in a patient undergoing ablative surgery requiring the removal of the mandibular condyle.
Temporomandibular joint disc
Dental
Class CA sterile interpositional implant or interarticular disc, intended to permanently interface between the natural mandibular condyle and natural glenoid fossa (mandibular fossa) in the temporomandibular joint (TMJ).
Tooth extraction forceps
Dental
Class AA hand-held manual dental surgical instrument shaped like pincers and designed for the extraction of teeth.
Transgingival implant
Dental
Class CA sterile device intended to be surgically implanted through the oral mucosa and gingiva to provide support and a means of retention for a dental prosthesis.
Transmandibular implant
Dental
Class CA sterile transosteal (transosseous) device [transmandibular implant (TMI)] intended to be surgically implanted through mandibular bone to provide support and a means of retention for a dental prosthesis, especially in a patient with an extremely atrophied/deformed mandible.
Ultrasonic dental scaling/debridement system
Dental
Class BAn assembly of powered devices intended for use by trained dental professionals to apply ultrasonic oscillations to: 1) removal of supragingival and subgingival dental deposits such as calculus, plaque, and biofilm from tooth surfaces during dental cleaning/periodontal therapy; and/or 2) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure.
Zinc phosphate dental cement
Dental
Class BA non-sterile substance intended for professional use as a dental cement and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an oxide powder [the principal constituent of which is zinc oxide (ZnO)] and an aqueous solution of phosphoric acid.
Zinc polycarboxylate dental cement
Dental
Class BA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid).
Data from CDSCO's online system for medical devices, retrieved 2026-10-31.
Sources
- Risk Classification Approved Device Details, CDSCO online system for medical devices. Retrieved 31 October 2026.
- Merged existing medical devices risk classification, CDSCO public notice, 1 January 2025.
See the full source list and how the data is compiled on the main classification page. This is a reference aid, not legal or regulatory advice.
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