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Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
PART 872--DENTAL DEVICES
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 | 872.1 | Scope. |
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| 872.3 | Effective dates of requirement for premarket approval. |
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| 872.9 | Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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| 872.1500 | Gingival fluid measurer. |
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| 872.1720 | Pulp tester. |
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| 872.1730 | Electrode gel for pulp testers. |
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| 872.1740 | Caries detection device. |
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| 872.1745 | Laser fluorescence caries detection device. |
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| 872.1800 | Extraoral source x-ray system. |
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| 872.1810 | Intraoral source x-ray system. |
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| 872.1820 | Dental x-ray exposure alignment device. |
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| 872.1830 | Cephalometer. |
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| 872.1840 | Dental x-ray position indicating device. |
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| 872.1850 | Lead-lined position indicator. |
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| 872.1870 | Sulfide detection device. |
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| 872.1905 | Dental x-ray film holder. |
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| 872.3050 | Amalgam alloy. |
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| 872.3060 | Gold-based alloys and precious metal alloys for clinical use. |
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| 872.3080 | Mercury and alloy dispenser. |
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| 872.3100 | Dental amalgamator. |
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| 872.3110 | Dental amalgam capsule. |
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| 872.3130 | Preformed anchor. |
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| 872.3140 | Resin applicator. |
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| 872.3150 | Articulator. |
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| 872.3165 | Precision attachment. |
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| 872.3200 | Resin tooth bonding agent. |
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| 872.3220 | Facebow. |
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| 872.3240 | Dental bur. |
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| 872.3250 | Calcium hydroxide cavity liner. |
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| 872.3260 | Cavity varnish. |
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| 872.3275 | Dental cement. |
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| 872.3285 | Preformed clasp. |
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| 872.3300 | Hydrophilic resin coating for dentures. |
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| 872.3310 | Coating material for resin fillings. |
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| 872.3330 | Preformed crown. |
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| 872.3350 | Gold or stainless steel cusp. |
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| 872.3360 | Preformed cusp. |
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| 872.3400 | Karaya and sodium borate with or without acacia denture adhesive. |
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| 872.3410 | Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive. |
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| 872.3420 | Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive. |
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| 872.3450 | Ethylene oxide homopolymer and/or karaya denture adhesive. |
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| 872.3480 | Polyacrylamide polymer (modified cationic) denture adhesive. |
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| 872.3490 | Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive. |
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| 872.3500 | Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive. |
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| 872.3520 | OTC denture cleanser. |
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| 872.3530 | Mechanical denture cleaner. |
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| 872.3540 | OTC denture cushion or pad. |
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| 872.3560 | OTC denture reliner. |
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| 872.3570 | OTC denture repair kit. |
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| 872.3580 | Preformed gold denture tooth. |
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| 872.3590 | Preformed plastic denture tooth. |
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| 872.3600 | Partially fabricated denture kit. |
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| 872.3640 | Endosseous implant. |
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| 872.3645 | Subperiosteal implant material. |
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| 872.3660 | Impression material. |
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| 872.3670 | Resin impression tray material. |
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| 872.3680 | Polytetrafluoroethylene (PTFE) vitreous carbon materials. |
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| 872.3690 | Tooth shade resin material. |
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| 872.3700 | Dental mercury. |
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| 872.3710 | Base metal alloy. |
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| 872.3730 | Pantograph. |
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| 872.3740 | Retentive and splinting pin. |
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| 872.3750 | Bracket adhesive resin and tooth conditioner. |
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| 872.3760 | Denture relining, repairing, or rebasing resin. |
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| 872.3765 | Pit and fissure sealant and conditioner. |
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| 872.3770 | Temporary crown and bridge resin. |
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| 872.3810 | Root canal post. |
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| 872.3820 | Root canal filling resin. |
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| 872.3830 | Endodontic paper point. |
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| 872.3840 | Endodontic silver point. |
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| 872.3850 | Gutta percha. |
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| 872.3890 | Endodontic stabilizing splint. |
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| 872.3900 | Posterior artificial tooth with a metal insert. |
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| 872.3910 | Backing and facing for an artificial tooth. |
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| 872.3920 | Porcelain tooth. |
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| 872.3930 | Tricalcium phosphate granules for dental bone repair. |
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| 872.3940 | Total temporomandibular joint prosthesis. |
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| 872.3950 | Glenoid fossa prosthesis. |
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| 872.3960 | Mandibular condyle prosthesis. |
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| 872.3970 | Interarticular disc prosthesis (interpositional implant). |
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| 872.3980 | Endosseous dental implant accessories. |
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| 872.4120 | Bone cutting instrument and accessories. |
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| 872.4130 | Intraoral dental drill. |
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| 872.4200 | Dental handpiece and accessories. |
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| 872.4465 | Gas-powered jet injector. |
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| 872.4475 | Spring-powered jet injector. |
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| 872.4535 | Dental diamond instrument. |
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| 872.4565 | Dental hand instrument. |
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| 872.4600 | Intraoral ligature and wire lock. |
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| 872.4620 | Fiber optic dental light. |
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| 872.4630 | Dental operating light. |
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| 872.4730 | Dental injecting needle. |
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| 872.4760 | Bone plate. |
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| 872.4840 | Rotary scaler. |
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| 872.4850 | Ultrasonic scaler. |
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| 872.4880 | Intraosseous fixation screw or wire. |
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| 872.4920 | Dental electrosurgical unit and accessories. |
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| 872.5410 | Orthodontic appliance and accessories. |
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| 872.5470 | Orthodontic plastic bracket. |
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| 872.5500 | Extraoral orthodontic headgear. |
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| 872.5525 | Preformed tooth positioner. |
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| 872.5550 | Teething ring. |
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| 872.6010 | Abrasive device and accessories. |
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| 872.6030 | Oral cavity abrasive polishing agent. |
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| 872.6050 | Saliva absorber. |
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| 872.6070 | Ultraviolet activator for polymerization. |
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| 872.6080 | Airbrush. |
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| 872.6100 | Anesthetic warmer. |
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| 872.6140 | Articulation paper. |
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| 872.6200 | Base plate shellac. |
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| 872.6250 | Dental chair and accessories. |
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| 872.6290 | Prophylaxis cup. |
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| 872.6300 | Rubber dam and accessories. |
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| 872.6350 | Ultraviolet detector. |
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| 872.6390 | Dental floss. |
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| 872.6475 | Heat source for bleaching teeth. |
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| 872.6510 | Oral irrigation unit. |
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| 872.6570 | Impression tube. |
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| 872.6640 | Dental operative unit and accessories. |
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| 872.6650 | Massaging pick or tip for oral hygiene. |
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| 872.6660 | Porcelain powder for clinical use. |
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| 872.6670 | Silicate protector. |
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| 872.6710 | Boiling water sterilizer. |
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| 872.6730 | Endodontic dry heat sterilizer. |
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| 872.6770 | Cartridge syringe. |
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| 872.6855 | Manual toothbrush. |
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| 872.6865 | Powered toothbrush. |
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| 872.6870 | Disposable flouride tray. |
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| 872.6880 | Preformed impression tray. |
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| 872.6890 | Intraoral dental wax. |
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