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Section 872.1
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Effective dates of requirement for premarket approval |
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Section 872.3
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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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Section 872.9
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Gingival fluid measurer |
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Section 872.1500
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Pulp tester |
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Section 872.1720
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Electrode gel for pulp testers |
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Section 872.1730
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Caries detection device |
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Section 872.1740
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Laser fluorescence caries detection device |
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Section 872.1745
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Extraoral source x-ray system |
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Section 872.1800
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Intraoral source x-ray system |
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Section 872.1810
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Dental x-ray exposure alignment device |
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Section 872.1820
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Cephalometer |
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Section 872.1830
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Dental x-ray position indicating device |
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Section 872.1840
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Lead-lined position indicator |
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Section 872.1850
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Sulfide detection device |
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Section 872.1870
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Dental x-ray film holder |
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Section 872.1905
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Dental sonography device |
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Section 872.2050
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Jaw tracking device |
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Section 872.2060
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Noble metal alloy |
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Section 872.3060
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Dental amalgam, mercury, and amalgam alloy |
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Section 872.3070
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Mercury and alloy dispenser |
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Section 872.3080
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Dental amalgamator |
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Section 872.3100
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Dental amalgam capsule |
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Section 872.3110
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Preformed anchor |
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Section 872.3130
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Resin applicator |
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Section 872.3140
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Articulator |
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Section 872.3150
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Precision attachment |
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Section 872.3165
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Resin tooth bonding agent |
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Section 872.3200
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Facebow |
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Section 872.3220
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Dental bur |
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Section 872.3240
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Calcium hydroxide cavity liner |
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Section 872.3250
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Cavity varnish |
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Section 872.3260
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Dental cement |
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Section 872.3275
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Preformed clasp |
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Section 872.3285
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Hydrophilic resin coating for dentures |
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Section 872.3300
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Coating material for resin fillings |
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Section 872.3310
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Preformed crown |
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Section 872.3330
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Gold or stainless steel cusp |
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Section 872.3350
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Preformed cusp |
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Section 872.3360
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Karaya and sodium borate with or without acacia denture adhesive |
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Section 872.3400
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Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive |
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Section 872.3410
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Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive |
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Section 872.3420
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Ethylene oxide homopolymer and/or karaya denture adhesive |
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Section 872.3450
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Polyacrylamide polymer (modified cationic) denture adhesive |
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Section 872.3480
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Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive |
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Section 872.3490
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Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive |
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Section 872.3500
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OTC denture cleanser |
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Section 872.3520
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Mechanical denture cleaner |
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Section 872.3530
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OTC denture cushion or pad |
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Section 872.3540
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OTC denture reliner |
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Section 872.3560
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OTC denture repair kit |
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Section 872.3570
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Preformed gold denture tooth |
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Section 872.3580
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Preformed plastic denture tooth |
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Section 872.3590
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Partially fabricated denture kit |
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Section 872.3600
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Endosseous dental implant abutment |
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Section 872.3630
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Endosseous dental implant |
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Section 872.3640
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Subperiosteal implant material |
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Section 872.3645
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Impression material |
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Section 872.3660
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Optical Impression Systems for CAD/CAM |
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Section 872.3661
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Resin impression tray material |
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Section 872.3670
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Polytetrafluoroethylene (PTFE) vitreous carbon materials |
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Section 872.3680
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Tooth shade resin material |
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Section 872.3690
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Base metal alloy |
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Section 872.3710
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Pantograph |
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Section 872.3730
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Retentive and splinting pin |
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Section 872.3740
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Bracket adhesive resin and tooth conditioner |
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Section 872.3750
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Denture relining, repairing, or rebasing resin |
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Section 872.3760
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Pit and fissure sealant and conditioner |
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Section 872.3765
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Temporary crown and bridge resin |
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Section 872.3770
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Root canal post |
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Section 872.3810
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Root canal filling resin |
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Section 872.3820
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Endodontic paper point |
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Section 872.3830
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Endodontic silver point |
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Section 872.3840
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Gutta percha |
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Section 872.3850
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Endodontic stabilizing splint |
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Section 872.3890
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Posterior artificial tooth with a metal insert |
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Section 872.3900
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Backing and facing for an artificial tooth |
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Section 872.3910
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Porcelain tooth |
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Section 872.3920
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Bone grafting material |
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Section 872.3930
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Total temporomandibular joint prosthesis |
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Section 872.3940
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Glenoid fossa prosthesis |
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Section 872.3950
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Mandibular condyle prosthesis |
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Section 872.3960
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Interarticular disc prosthesis (interpositional implant) |
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Section 872.3970
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Endosseous dental implant accessories |
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Section 872.3980
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Bone cutting instrument and accessories |
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Section 872.4120
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Intraoral dental drill |
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Section 872.4130
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Dental handpiece and accessories |
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Section 872.4200
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Gas-powered jet injector |
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Section 872.4465
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Spring-powered jet injector |
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Section 872.4475
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Dental diamond instrument |
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Section 872.4535
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Dental hand instrument |
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Section 872.4565
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Intraoral ligature and wire lock |
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Section 872.4600
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Fiber optic dental light |
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Section 872.4620
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Dental operating light |
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Section 872.4630
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Dental injecting needle |
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Section 872.4730
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Bone plate |
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Section 872.4760
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Temporary mandibular condyle reconstruction plate |
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Section 872.4770
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Rotary scaler |
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Section 872.4840
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Ultrasonic scaler |
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Section 872.4850
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Intraosseous fixation screw or wire |
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Section 872.4880
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Dental electrosurgical unit and accessories |
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Section 872.4920
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Orthodontic appliance and accessories |
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Section 872.5410
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Orthodontic plastic bracket |
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Section 872.5470
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Extraoral orthodontic headgear |
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Section 872.5500
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Preformed tooth positioner |
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Section 872.5525
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Teething ring |
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Section 872.5550
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Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea |
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Section 872.5570
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Oral rinse to reduce the adhesion of dental plaque |
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Section 872.5580
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Abrasive device and accessories |
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Section 872.6010
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Oral cavity abrasive polishing agent |
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Section 872.6030
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Saliva absorber |
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Section 872.6050
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Ultraviolet activator for polymerization |
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Section 872.6070
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Airbrush |
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Section 872.6080
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Anesthetic warmer |
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Section 872.6100
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Articulation paper |
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Section 872.6140
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Base plate shellac |
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Section 872.6200
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Dental chair and accessories |
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Section 872.6250
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Prophylaxis cup |
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Section 872.6290
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Rubber dam and accessories |
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Section 872.6300
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Ultraviolet detector |
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Section 872.6350
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Dental floss |
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Section 872.6390
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Heat source for bleaching teeth |
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Section 872.6475
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Oral irrigation unit |
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Section 872.6510
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Impression tube |
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Section 872.6570
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Dental operative unit and accessories |
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Section 872.6640
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Massaging pick or tip for oral hygiene |
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Section 872.6650
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Porcelain powder for clinical use |
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Section 872.6660
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Silicate protector |
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Section 872.6670
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Boiling water sterilizer |
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Section 872.6710
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Endodontic dry heat sterilizer |
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Section 872.6730
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Cartridge syringe |
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Section 872.6770
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Manual toothbrush |
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Section 872.6855
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Powered toothbrush |
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Section 872.6865
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Disposable fluoride tray |
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Section 872.6870
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Preformed impression tray |
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Section 872.6880
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Intraoral dental wax |
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Section 872.6890
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Scope |