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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 872 - Dental 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 - XXX |
| Subpart D - Prosthetic Devices |
| § 872.3050 - Amalgam alloy. |
| § 872.3060 - Noble metal alloy. |
| § 872.3070 - Dental amalgam, mercury, and amalgam alloy. |
| § 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 - Bone grafting material. |
| § 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. |
| § 872.4770 - Temporary mandibular condyle reconstruction 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. |
| § 872.5560 - Electrical salivary stimulatory system. |
| § 872.5570 - Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. |
| § 872.5571 - Auto titration device for oral appliances. |
| § 872.5580 - Oral rinse to reduce the adhesion of dental plaque. |
| 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 fluoride tray. |
| § 872.6880 - Preformed impression tray. |
| § 872.6890 - Intraoral dental wax. |