FDA medical devices classification list

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

    - Scope.
    - Effective dates of requirement for premarket approval.
    - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    - Gingival fluid measurer.
    - Pulp tester.
    - Electrode gel for pulp testers.
    - Caries detection device.
    - Laser fluorescence caries detection device.
    - Extraoral source x-ray system.
    - Intraoral source x-ray system.
    - Dental x-ray exposure alignment device.
    - Cephalometer.
    - Dental x-ray position indicating device.
    - Lead-lined position indicator.
    - Sulfide detection device.
    - Dental x-ray film holder.
    - Dental sonography device.
    - Jaw tracking device.

Subpart C [Reserved]

    - Noble metal alloy.
    - Dental amalgam, mercury, and amalgam alloy.
    - Mercury and alloy dispenser.
    - Dental amalgamator.
    - Dental amalgam capsule.
    - Preformed anchor.
    - Resin applicator.
    - Articulator.
    - Precision attachment.
    - Resin tooth bonding agent.
    - Facebow.
    - Dental bur.
    - Calcium hydroxide cavity liner.

    - Cavity varnish.
    - Dental cement.
    - Preformed clasp.
    - Hydrophilic resin coating for dentures.
    - Coating material for resin fillings.
    - Preformed crown.
    - Gold or stainless steel cusp.
    - Preformed cusp.
    - Karaya and sodium borate with or without acacia denture adhesive.
    - Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive.
    - Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive.
    - Ethylene oxide homopolymer and/or karaya denture adhesive.
    - Polyacrylamide polymer (modified cationic) denture adhesive.
    - Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive.
    - Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.
    - OTC denture cleanser.
    - Mechanical denture cleaner.
    - OTC denture cushion or pad.
    - OTC denture reliner.
    - OTC denture repair kit.
    - Preformed gold denture tooth.
    - Preformed plastic denture tooth.
    - Partially fabricated denture kit.
    - Endosseous dental implant abutment.
    - Endosseous dental implant.
    - Subperiosteal implant material.
    - Impression material.
    - Optical Impression Systems for CAD/CAM.
    - Resin impression tray material.
    - Polytetrafluoroethylene (PTFE) vitreous carbon materials.
    - Tooth shade resin material.
    - Base metal alloy.
    - Pantograph.
    - Retentive and splinting pin.
    - Bracket adhesive resin and tooth conditioner.
    - Denture relining, repairing, or rebasing resin.
    - Pit and fissure sealant and conditioner.
    - Temporary crown and bridge resin.
    - Root canal post.
    - Root canal filling resin.

  - Endodontic paper point.
    - Endodontic silver point.
    - Gutta percha.
    - Endodontic stabilizing splint.
    - Posterior artificial tooth with a metal insert.
    - Backing and facing for an artificial tooth.
    - Porcelain tooth.
    - Bone grafting material.
    - Total temporomandibular joint prosthesis.
    - Glenoid fossa prosthesis.
    - Mandibular condyle prosthesis.
    - Interarticular disc prosthesis (interpositional implant).
    - Endosseous dental implant accessories.

    - Bone cutting instrument and accessories.
    - Intraoral dental drill.
    - Dental handpiece and accessories.
    - Gas-powered jet injector.
    - Spring-powered jet injector.
    - Dental diamond instrument.
    - Dental hand instrument.
    - Intraoral ligature and wire lock.
    - Fiber optic dental light.
    - Dental operating light.
    - Dental injecting needle.
    - Bone plate.
    - Temporary mandibular condyle reconstruction plate.
    - Rotary scaler.
    - Ultrasonic scaler.
    - Intraosseous fixation screw or wire.
    - Dental electrosurgical unit and accessories.

    - Orthodontic appliance and accessories.
    - Orthodontic plastic bracket.
    - Extraoral orthodontic headgear.
    - Preformed tooth positioner.
    - Teething ring.
    - Electrical salivary stimulatory system.
    - Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
    - Auto titration device for oral appliances.
    - Oral rinse to reduce the adhesion of dental plaque.

    - Abrasive device and accessories.
    - Oral cavity abrasive polishing agent.
    - Saliva absorber.
    - Ultraviolet activator for polymerization.
    - Airbrush.
    - Anesthetic warmer.
    - Articulation paper.
    - Base plate shellac.
    - Dental chair and accessories.
    - Prophylaxis cup.
    - Rubber dam and accessories.
    - Ultraviolet detector.
    - Dental floss.
    - Heat source for bleaching teeth.
    - Oral irrigation unit.
    - Impression tube.
    - Dental operative unit and accessories.
    - Massaging pick or tip for oral hygiene.
    - Porcelain powder for clinical use.
    - Silicate protector.
    - Boiling water sterilizer.
    - Endodontic dry heat sterilizer.
    - Cartridge syringe.
    - Manual toothbrush.
    - Powered toothbrush.
    - Disposable fluoride tray.
    - Preformed impression tray.
    - Intraoral dental wax.

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.

Extracted from US.FDA