21 C.F.R. PART 872--DENTAL DEVICES
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872--DENTAL DEVICES
Subpart A--GENERAL PROVISIONS
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Effective dates of requirement for premarket approval.
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Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B--DIAGNOSTIC DEVICES
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Electrode gel for pulp testers.
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Laser fluorescence caries detection device.
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Extraoral source x-ray system.
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Intraoral source x-ray system.
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Dental x-ray exposure alignment device.
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Dental x-ray position indicating device.
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Lead-lined position indicator.
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Sulfide detection device.
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Dental x-ray film holder.
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Dental sonography device.
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Subpart C--[RESERVED]
Subpart D--PROSTHETIC DEVICES
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Mercury and alloy dispenser.
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Resin tooth bonding agent.
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Calcium hydroxide cavity liner.
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Hydrophilic resin coating for dentures.
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Coating material for resin fillings.
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Gold or stainless steel cusp.
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Karaya and sodium borate with or without acacia denture adhesive.
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Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive.
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Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive.
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Ethylene oxide homopolymer and/or karaya denture adhesive.
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Polyacrylamide polymer (modified cationic) denture adhesive.
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Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive.
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Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.
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Mechanical denture cleaner.
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OTC denture cushion or pad.
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Preformed gold denture tooth.
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Preformed plastic denture tooth.
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Partially fabricated denture kit.
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Endosseous dental implant abutment.
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Endosseous dental implant.
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Subperiosteal implant material.
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Optical Impression Systems for CAD/CAM.
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Resin impression tray material.
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Polytetrafluoroethylene (PTFE) vitreous carbon materials.
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Tooth shade resin material.
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Retentive and splinting pin.
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Bracket adhesive resin and tooth conditioner.
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Denture relining, repairing, or rebasing resin.
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Pit and fissure sealant and conditioner.
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Temporary crown and bridge resin.
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Root canal filling resin.
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Endodontic stabilizing splint.
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Posterior artificial tooth with a metal insert.
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Backing and facing for an artificial tooth.
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Total temporomandibular joint prosthesis.
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Glenoid fossa prosthesis.
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Mandibular condyle prosthesis.
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Interarticular disc prosthesis (interpositional implant).
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Endosseous dental implant accessories.
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Subpart E--SURGICAL DEVICES
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Bone cutting instrument and accessories.
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Dental handpiece and accessories.
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Gas-powered jet injector.
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Spring-powered jet injector.
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Dental diamond instrument.
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Intraoral ligature and wire lock.
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Fiber optic dental light.
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Intraosseous fixation screw or wire.
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Dental electrosurgical unit and accessories.
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Subpart F--THERAPEUTIC DEVICES
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Orthodontic appliance and accessories.
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Orthodontic plastic bracket.
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Extraoral orthodontic headgear.
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Preformed tooth positioner.
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Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
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Oral rinse to reduce the adhesion of dental plaque.
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Subpart G--MISCELLANEOUS DEVICES
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Abrasive device and accessories.
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Oral cavity abrasive polishing agent.
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Ultraviolet activator for polymerization.
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Dental chair and accessories.
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Rubber dam and accessories.
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Heat source for bleaching teeth.
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Dental operative unit and accessories.
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Massaging pick or tip for oral hygiene.
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Porcelain powder for clinical use.
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Boiling water sterilizer.
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Endodontic dry heat sterilizer.
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Disposable flouride tray.
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Preformed impression tray.
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