Title 21, Part 872 — Dental 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.

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.

Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea.

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.

Radiofrequency toothbrush.

Disposable fluoride tray.

Preformed impression tray.

Intraoral dental wax.