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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