TITLE 21--FOOD AND DRUGS SUBCHAPTER H - MEDICAL DEVICES Subpart A -- General Provisions § 872.1 - Scope. § 872.3 - Effective dates of requirement for premarket approval. § 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). Subpart B -- Diagnostic Devices § 872.1500 - Gingival fluid measurer. § 872.1720 - Pulp tester. § 872.1730 - Electrode gel for pulp testers. § 872.1740 - Caries detection device. § 872.1745 - Laser fluorescence caries detection device. § 872.1800 - Extraoral source x-ray system. § 872.1810 - Intraoral source x-ray system. § 872.1820 - Dental x-ray exposure alignment device. § 872.1830 - Cephalometer. § 872.1840 - Dental x-ray position indicating device. § 872.1850 - Lead-lined position indicator. § 872.1870 - Sulfide detection device. § 872.1905 - Dental x-ray film holder. § 872.2050 - Dental sonography device. § 872.2060 - Jaw tracking device. Subpart C [Reserved] Subpart D -- Prosthetic Devices § 872.3050 - Amalgam alloy. § 872.3060 - Gold-based alloys and precious metal alloys for clinical use. § 872.3080 - Mercury and alloy dispenser. § 872.3100 - Dental amalgamator. § 872.3110 - Dental amalgam capsule. § 872.3130 - Preformed anchor. § 872.3140 - Resin applicator. § 872.3150 - Articulator. § 872.3165 - Precision attachment. § 872.3200 - Resin tooth bonding agent. § 872.3220 - Facebow. § 872.3240 - Dental bur. § 872.3250 - Calcium hydroxide cavity liner. § 872.3260 - Cavity varnish. § 872.3275 - Dental cement. § 872.3285 - Preformed clasp. § 872.3300 - Hydrophilic resin coating for dentures. § 872.3310 - Coating material for resin fillings. § 872.3330 - Preformed crown. § 872.3350 - Gold or stainless steel cusp. § 872.3360 - Preformed cusp. § 872.3400 - Karaya and sodium borate with or without acacia denture adhesive. § 872.3410 - Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive. § 872.3420 - Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive. § 872.3450 - Ethylene oxide homopolymer and/or karaya denture adhesive. § 872.3480 - Polyacrylamide polymer (modified cationic) denture adhesive. § 872.3490 - Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive. § 872.3500 - Polyvinylmethylether maleic anhydride (PVM–MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive. § 872.3520 - OTC denture cleanser. § 872.3530 - Mechanical denture cleaner. § 872.3540 - OTC denture cushion or pad. § 872.3560 - OTC denture reliner. § 872.3570 - OTC denture repair kit. § 872.3580 - Preformed gold denture tooth. § 872.3590 - Preformed plastic denture tooth. § 872.3600 - Partially fabricated denture kit. § 872.3630 - Endosseous dental implant abutment. § 872.3640 - Endosseous dental implant. § 872.3645 - Subperiosteal implant material. § 872.3660 - Impression material. § 872.3661 - Optical Impression Systems for CAD/CAM. § 872.3670 - Resin impression tray material. § 872.3680 - Polytetrafluoroethylene (PTFE) vitreous carbon materials. § 872.3690 - Tooth shade resin material. § 872.3700 - Dental mercury. § 872.3710 - Base metal alloy. § 872.3730 - Pantograph. § 872.3740 - Retentive and splinting pin. § 872.3750 - Bracket adhesive resin and tooth conditioner. § 872.3760 - Denture relining, repairing, or rebasing resin. § 872.3765 - Pit and fissure sealant and conditioner. § 872.3770 - Temporary crown and bridge resin. § 872.3810 - Root canal post. § 872.3820 - Root canal filling resin. § 872.3830 - Endodontic paper point. § 872.3840 - Endodontic silver point. § 872.3850 - Gutta percha. § 872.3890 - Endodontic stabilizing splint. § 872.3900 - Posterior artificial tooth with a metal insert. § 872.3910 - Backing and facing for an artificial tooth. § 872.3920 - Porcelain tooth. § 872.3930 - Tricalcium phosphate granules for dental bone repair. § 872.3940 - Total temporomandibular joint prosthesis. § 872.3950 - Glenoid fossa prosthesis. § 872.3960 - Mandibular condyle prosthesis. § 872.3970 - Interarticular disc prosthesis (interpositional implant). § 872.3980 - Endosseous dental implant accessories. Subpart E -- Surgical Devices § 872.4120 - Bone cutting instrument and accessories. § 872.4130 - Intraoral dental drill. § 872.4200 - Dental handpiece and accessories. § 872.4465 - Gas-powered jet injector. § 872.4475 - Spring-powered jet injector. § 872.4535 - Dental diamond instrument. § 872.4565 - Dental hand instrument. § 872.4600 - Intraoral ligature and wire lock. § 872.4620 - Fiber optic dental light. § 872.4630 - Dental operating light. § 872.4730 - Dental injecting needle. § 872.4760 - Bone plate. § 872.4840 - Rotary scaler. § 872.4850 - Ultrasonic scaler. § 872.4880 - Intraosseous fixation screw or wire. § 872.4920 - Dental electrosurgical unit and accessories. Subpart F -- Therapeutic Devices § 872.5410 - Orthodontic appliance and accessories. § 872.5470 - Orthodontic plastic bracket. § 872.5500 - Extraoral orthodontic headgear. § 872.5525 - Preformed tooth positioner. § 872.5550 - Teething ring. § 872.5570 - Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. Subpart G -- Miscellaneous Devices § 872.6010 - Abrasive device and accessories. § 872.6030 - Oral cavity abrasive polishing agent. § 872.6050 - Saliva absorber. § 872.6070 - Ultraviolet activator for polymerization. § 872.6080 - Airbrush. § 872.6100 - Anesthetic warmer. § 872.6140 - Articulation paper. § 872.6200 - Base plate shellac. § 872.6250 - Dental chair and accessories. § 872.6290 - Prophylaxis cup. § 872.6300 - Rubber dam and accessories. § 872.6350 - Ultraviolet detector. § 872.6390 - Dental floss. § 872.6475 - Heat source for bleaching teeth. § 872.6510 - Oral irrigation unit. § 872.6570 - Impression tube. § 872.6640 - Dental operative unit and accessories. § 872.6650 - Massaging pick or tip for oral hygiene. § 872.6660 - Porcelain powder for clinical use. § 872.6670 - Silicate protector. § 872.6710 - Boiling water sterilizer. § 872.6730 - Endodontic dry heat sterilizer. § 872.6770 - Cartridge syringe. § 872.6855 - Manual toothbrush. § 872.6865 - Powered toothbrush. § 872.6870 - Disposable flouride tray. § 872.6880 - Preformed impression tray. § 872.6890 - Intraoral dental wax. |