PART 872—DENTAL DEVICES Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted. Editorial Note: Nomenclature changes to part 872 appear at 73 FR 35341, June 23, 2008. Subpart A—General Provisions § 872.1 Scope. (a) This part sets forth the classification of dental devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87. (c) To avoid duplicative listings, a dental device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed in one subpart only. (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. (e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. [52 FR 30097, Aug. 12, 1987, as amended at 68 FR 19737, Apr. 22, 2003; 79 FR 50552, Aug. 25, 2014] § 872.3 Effective dates of requirement for premarket approval. A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. (a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act, FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraphs (b) and (c) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device. (b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. (c) A device identified in a regulation in this part that is classified into class III and that is subject to the transitional provisions of section 520(1) of the act is automatically classified by statute into class III and must have an approval under section 515 of the act before being commercially distributed. Accordingly, the regulation for such a class III transitional device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. § 872.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or (c) The device is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in § 812.3(k) of this chapter; and (9) For near patient testing (point of care). [65 FR 2314, Jan. 14, 2000] Subpart B—Diagnostic Devices § 872.1500 Gingival fluid measurer. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38797, July 25, 2001] § 872.1720 Pulp tester. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019] § 872.1730 Electrode gel for pulp testers. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001] § 872.1740 Caries detection device. (a) Identification. (b) Classification. § 872.1745 Laser fluorescence caries detection device. (a) Identification. (b) Classification. (1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter; (2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and (3) The labeling must include detailed use instructions with precautions that urge users to: (i) Read and understand all directions before using the device, (ii) Store probe tips under proper conditions, (iii) Properly sterilize the emitter-detector handpick before each use, and (iv) Properly maintain and handle the instrument in the specified manner and condition. [65 FR 18235, Apr. 7, 2000] § 872.1800 Extraoral source x-ray system. (a) Identification. (b) Classification. § 872.1810 Intraoral source x-ray system. (a) Identification. (b) Classification. § 872.1820 Dental x-ray exposure alignment device. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, 2001] § 872.1830 Cephalometer. (a) Identification. (b) Classification. § 872.1840 Dental x-ray position indicating device. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38797, July 25, 2001] § 872.1850 Lead-lined position indicator. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38797, July 25, 2001] § 872.1870 Sulfide detection device. (a) Identification. (b) Classification. [63 FR 59717, Nov. 5, 1998] § 872.1905 Dental x-ray film holder. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001; 90 FR 55983, Dec. 4, 2025] § 872.2050 Dental sonography device. (a) Dental sonography device for monitoring Identification. (2) Classification. (b) Dental sonography device for interpretation and diagnosis Identification. (2) Classification. [68 FR 67367, Dec. 2, 2003] § 872.2060 Jaw tracking device. (a) Jaw tracking device for monitoring mandibular jaw positions relative to the maxilla Identification. (2) Classification. (b) Jaw tracking device for interpretation of mandibular jaw positions for the diagnosis Identification. (2) Classification. [68 FR 67367, Dec. 2, 2003] Subpart C [Reserved] Subpart D—Prosthetic Devices § 872.3060 Noble metal alloy. (a) Identification. (b) Classification. [69 FR 51766, Aug. 23, 2004] § 872.3070 Dental amalgam, mercury, and amalgam alloy. (a) Identification. (b) Classification. See [74 FR 38714, Aug. 4, 2009] § 872.3080 Mercury and alloy dispenser. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001] § 872.3100 Dental amalgamator. (a) Identification. (b) Classification. [55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, 2001] § 872.3110 Dental amalgam capsule. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001] § 872.3130 Preformed anchor. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, 2001] § 872.3140 Resin applicator. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001; 90 FR 55983, Dec. 4, 2025] § 872.3150 Articulator. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001; 90 FR 55983, Dec. 4, 2025] § 872.3165 Precision attachment. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, 2001] § 872.3200 Resin tooth bonding agent. (a) Identification. (b) Classification. § 872.3220 Facebow. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001; 90 FR 55983, Dec. 4, 2025] § 872.3240 Dental bur. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001] § 872.3250 Calcium hydroxide cavity liner. (a) Identification. (b) Classification. § 872.3260 Cavity varnish. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019] § 872.3275 Dental cement. (a) Zinc oxide-eugenol Identification. (2) Classification. (b) Dental cement other than zinc oxide-eugenol Identification. (2) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 65 FR 2314, Jan. 14, 2000] § 872.3285 Preformed clasp. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001] § 872.3300 Hydrophilic resin coating for dentures. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019] § 872.3310 Coating material for resin fillings. (a) Identification. (b) Classification. § 872.3330 Preformed crown. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001] § 872.3350 Gold or stainless steel cusp. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001] § 872.3360 Preformed cusp. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001] § 872.3400 Karaya and sodium borate with or without acacia denture adhesive. (a) Identification. (b) Classification. (2) Class III if the device contains 12 percent or more by weight of sodium borate. (c) Date PMA or notice of completion of a PDP is required. [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50706, Sept. 27, 1996; 65 FR 2315, Jan. 14, 2000] § 872.3410 Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001] § 872.3420 Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996] § 872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 65 FR 2315, Jan. 14, 2000] § 872.3480 Polyacrylamide polymer (modified cationic) denture adhesive. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996] § 872.3490 Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001] § 872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996] § 872.3520 OTC denture cleanser. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001] § 872.3530 Mechanical denture cleaner. (a) Identification. (b) Classification. [55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001] § 872.3540 OTC denture cushion or pad. (a) Identification. (b) Classification. (2) Class II (special controls) if the OTC denture cushion or pad is made of a material other than wax-impregnated cotton cloth or if the intended use of the device differs from that described in paragraph (b)(1) of this section. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. The special controls for this device are FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical—Devices Part I: Evaluation and Testing,’ ” and (ii) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.” [52 FR 30097, Aug. 12, 1987, as amended at 65 FR 2315, 2000; 65 FR 17144, Mar. 31, 2000; 84 FR 71812, Dec. 30, 2019] § 872.3560 OTC denture reliner. (a) Identification. (b) Classification. (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and (2) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.” [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996; 65 FR 17144, Mar. 31, 2000; 84 FR 71812, Dec. 30, 2019] § 872.3570 OTC denture repair kit. (a) Identification. (b) Classification. (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and (2) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.” [52 FR 30097, Aug. 12, 1987, as amended at 65 FR 17144, Mar. 31, 2000; 83 FR 11145, Mar. 14, 2018] § 872.3580 Preformed gold denture tooth. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001] § 872.3590 Preformed plastic denture tooth. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019] § 872.3600 Partially fabricated denture kit. (a) Identification. (b) Classification. (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and (2) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.” [52 FR 30097, Aug. 12, 1987, as amended at 65 FR 17144, Mar. 31, 2000; 84 FR 71812, Dec. 30, 2019] § 872.3630 Endosseous dental implant abutment. (a) Identification. (b) Classification. [69 FR 26304, May 12, 2004] § 872.3640 Endosseous dental implant. (a) Identification. (b) Classification. (2) Classification. (i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use. [69 FR 26304, May 12, 2004, as amended at 79 FR 34625, June 18, 2014] § 872.3645 Subperiosteal implant material. (a) Identification. (b) Classification. § 872.3660 Impression material. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 68 FR 19738, Apr. 22, 2003] § 872.3661 Optical Impression Systems for CAD/CAM. (a) Identification. (b) Classification. [68 FR 19738, Apr. 22, 2003] § 872.3670 Resin impression tray material. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001; 90 FR 55983, Dec. 4, 2025] § 872.3680 Polytetrafluoroethylene (PTFE) vitreous carbon materials. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987; 52 FR 34456, Sept. 11, 1987] § 872.3690 Tooth shade resin material. (a) Identification. (b) Classification. § 872.3710 Base metal alloy. (a) Identification. (b) Classification. [69 FR 51766, Aug. 23, 2004] § 872.3730 Pantograph. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 66 FR 38798, July 25, 2001; 90 FR 55984, Dec. 4, 2025] § 872.3740 Retentive and splinting pin. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 60 FR 38900, July 28, 1995; 66 FR 38798, July 25, 2001] § 872.3750 Bracket adhesive resin and tooth conditioner. (a) Identification. (b) Classification. § 872.3760 Denture relining, repairing, or rebasing resin. (a) Identification. (b) Classification. § 872.3765 Pit and fissure sealant and conditioner. (a) Identification. (b) Classification. § 872.3770 Temporary crown and bridge resin. (a) Identification. (b) Classification. § 872.3810 Root canal post. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 60 FR 38900, July 28, 1995; 66 FR 38798, July 25, 2001] § 872.3820 Root canal filling resin. (a) Identification. (b) Classification. (2) Class III if chloroform is used as an ingredient in the device. (c) Date PMA or notice of completion of a PDP is required. [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996] § 872.3830 Endodontic paper point. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38798, July 25, 2001] § 872.3840 Endodontic silver point. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38798, July 25, 2001] § 872.3850 Gutta percha. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38798, July 25, 2001] § 872.3890 Endodontic stabilizing splint. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019] § 872.3900 Posterior artificial tooth with a metal insert. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001] § 872.3910 Backing and facing for an artificial tooth. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38799, July 25, 2001] § 872.3920 Porcelain tooth. (a) Identification. (b) Classification. § 872.3930 Bone grafting material. (a) Identification. (b) Classification. (2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. [70 FR 21949, Apr. 28, 2005] § 872.3940 Total temporomandibular joint prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [59 FR 65478, Dec. 20, 1994, as amended at 63 FR 71746, Dec. 30, 1998] § 872.3950 Glenoid fossa prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [59 FR 65478, Dec. 20, 1994, as amended at 63 FR 71746, Dec. 30, 1998] § 872.3960 Mandibular condyle prosthesis. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [59 FR 65478, Dec. 20, 1994, as amended at 63 FR 71746, Dec. 30, 1998; 78 FR 79310, Dec. 30, 2013] § 872.3970 Interarticular disc prosthesis (interpositional implant). (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [59 FR 65478, Dec. 20, 1994, as amended at 63 FR 71746, Dec. 30, 1998] § 872.3980 Endosseous dental implant accessories. (a) Identification. (b) Classification. [65 FR 60099, Oct. 10, 2000] Subpart E—Surgical Devices § 872.4120 Bone cutting instrument and accessories. (a) Identification. (b) Classification. § 872.4130 Intraoral dental drill. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38799, July 25, 2001] § 872.4200 Dental handpiece and accessories. (a) Identification. (b) Classification. [55 FR 48439, Nov. 20, 1990] § 872.4465 Gas-powered jet injector. (a) Identification. (b) Classification. § 872.4475 Spring-powered jet injector. (a) Identification. (b) Classification. § 872.4535 Dental diamond instrument. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994] § 872.4565 Dental hand instrument. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38799, July 25, 2001] § 872.4600 Intraoral ligature and wire lock. (a) Identification. (b) Classification. § 872.4620 Fiber optic dental light. (a) Identification. (b) Classification. [55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38799, July 25, 2001] § 872.4630 Dental operating light. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38799, July 25, 2001] § 872.4730 Dental injecting needle. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38799, July 25, 2001] § 872.4760 Bone plate. (a) Identification. (b) Classification. § 872.4770 Temporary mandibular condyle reconstruction plate. (a) Identification. (b) Classification. [78 FR 79310, Dec. 30, 2013] § 872.4840 Rotary scaler. (a) Identification. (b) Classification. § 872.4850 Ultrasonic scaler. (a) Identification. (b) Classification. § 872.4880 Intraosseous fixation screw or wire. (a) Identification. (b) Classification. § 872.4920 Dental electrosurgical unit and accessories. (a) Identification. (b) Classification. Subpart F—Therapeutic Devices § 872.5410 Orthodontic appliance and accessories. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, 2001] § 872.5470 Orthodontic plastic bracket. (a) Identification. (b) Classification. § 872.5500 Extraoral orthodontic headgear. (a) Identification. (b) Classification. § 872.5525 Preformed tooth positioner. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, 2001] § 872.5550 Teething ring. (a) Identification. (b)(1) Classification. (2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 84 FR 71812, Dec. 30, 2019] § 872.5560 Electrical salivary stimulatory system. (a) Identification. (b) Classification (1) The design characteristics of the device must ensure that the device design, material composition, and electrical output characteristics are consistent with the intended use; (2) Any element of the device that contacts the patient must be demonstrated to be biocompatible; (3) Appropriate analysis and/or testing must validate electromagnetic compatibility and electrical safety, including the safety of any battery used in the device; (4) Software validation, verification, and hazard testing must be performed; and (5) Documented clinical experience must demonstrate safe and effective use for stimulating saliva production by addressing the risks of damage to intraoral tissue and of ineffective treatment and must capture any adverse events observed during clinical use. [80 FR 72586, Nov. 22, 2015] § 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. (a) Identification. (b) Classification. [67 FR 68512, Nov. 12, 2002] § 872.5571 Auto titration device for oral appliances. (a) Identification. (b) Classification. (1) Clinical performance testing must evaluate the following: (i) Performance characteristics of the algorithm; and (ii) All adverse events. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following: (i) Validation of the closed loop algorithm; (ii) Mechanical integrity over the expected use life; (iii) Characterization of maximum force, distance, and speed of device movement; and (iv) Movement accuracy of intraoral components. (3) Performance testing must demonstrate the wireless compatibility, electrical safety, and electromagnetic compatibility of the device in its intended use environment. (4) Software verification, validation, and hazard analysis must be performed. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Performance data must validate the reprocessing instructions for any reusable components. (7) Patient labeling must include: (i) Information on device use, including placement of sensors and mouthpieces; (ii) A description of all alarms; and (iii) Instructions for reprocessing any reusable components. (8) A human factors assessment must evaluate simulated use of the device in a home use setting. [84 FR 5000, Feb. 20, 2019] § 872.5575 Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea. (a) Identification. (b) Classification. (1) Performance testing must demonstrate the wireless compatibility, electrical safety, battery safety, and electromagnetic compatibility of the device in its intended use environment. (2) Software verification, validation, and hazard analysis must be performed. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Patient labeling must include: (i) Information on device components, setup, and use of the device including placement of sensors and mouthpieces, and images or illustrations; (ii) A summary of technical specifications; (iii) Instructions on how to clean and maintain the device; (iv) A statement that the patient should maintain regular follow up visits with dentist and sleep specialist; and (v) A statement that patients should have a comprehensive dental examination prior to using this device. (5) A human factors assessment must evaluate simulated use of the device to demonstrate that the user can correctly use device based on the labeling and instructions for use. [89 FR 71154, Sept. 3, 2024] § 872.5580 Oral rinse to reduce the adhesion of dental plaque. (a) Identification. (b) Classification. [70 FR 55028, Sept. 20, 2005] § 872.5590 Intraoral cooling device. (a) Identification. (b) Classification. (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Thermal testing to evaluate cooling consistency and performance; and (ii) Testing of the device to demonstrate material integrity. (2) Electromagnetic compatibility and electrical safety testing must be performed for any electrical components. (3) Software verification, validation, and hazard analysis must be performed for any software components of the device. (4) The patient contacting components of the device must be demonstrated to be biocompatible. (5) Labeling must include the following: (i) A summary of the device specifications, including temperature cooling range and duration of cooling; and (ii) Instructions to stop the use of the device if skin irritation or sensitivities develop, or if the device leaks or does not maintain its material integrity. [91 FR 32344, June 1, 2026] Subpart G—Miscellaneous Devices § 872.6010 Abrasive device and accessories. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38799, July 25, 2001; 90 FR 55984, Dec. 4, 2025] § 872.6030 Oral cavity abrasive polishing agent. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, 2001] § 872.6050 Saliva absorber. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38799, July 25, 2001; 90 FR 55984, Dec. 4, 2025] § 872.6070 Ultraviolet activator for polymerization. (a) Identification. (b) Classification. § 872.6080 Airbrush. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987; 52 FR 49250, Dec. 30, 1987, as amended at 71 FR 17144, Mar. 31, 2006] § 872.6100 Anesthetic warmer. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 60 FR 38900, July 28, 1995; 66 FR 38799, July 25, 2001] § 872.6140 Articulation paper. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, 2001; 90 FR 55984, Dec. 4, 2025] § 872.6200 Base plate shellac. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38799, July 25, 2001; 90 FR 55984, Dec. 4, 2025] § 872.6250 Dental chair and accessories. (a) Identification. (b) Classification. [55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994] § 872.6290 Prophylaxis cup. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989; 66 FR 38799, July 25, 2001; 90 FR 55984, Dec. 4, 2025] § 872.6300 Rubber dam and accessories. (a) Identification. (b) Classification. [65 FR 2315, Jan. 14, 2000, as amended at 90 FR 55984, Dec. 4, 2025] § 872.6350 Ultraviolet detector. (a) Identification. (b) Classification. § 872.6390 Dental floss. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 65 FR 2315, Jan. 14, 2000] § 872.6475 Heat source for bleaching teeth. (a) Identification. (b) Classification. [55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, 2001] § 872.6510 Oral irrigation unit. (a) Identification. (b) Classification. [55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, 2001] § 872.6570 Impression tube. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, 2001; 90 FR 55984, Dec. 4, 2025] § 872.6640 Dental operative unit and accessories. (a) Identification. (b) Classification. [55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 65 FR 2315, Jan. 14, 2000] § 872.6650 Massaging pick or tip for oral hygiene. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, 2001; 90 FR 55984, Dec. 4, 2025] § 872.6660 Porcelain powder for clinical use. (a) Identification. (b) Classification. § 872.6670 Silicate protector. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, 2001; 90 FR 55984, Dec. 4, 2025] § 872.6710 Boiling water sterilizer. (a) Identification. (b) Classification. [55 FR 48439, Nov. 20, 1990, as amended at 66 FR 46952, Sept. 10, 2001] § 872.6730 Endodontic dry heat sterilizer. (a) Identification. (b) Classification. (c) Date premarket approval application PMA or notice of completion of product development protocol PDP is required. [52 FR 30097, Aug. 12, 1987, as amended at 62 FR 2902, Jan. 21, 1997; 62 FR 31512, June 10, 1997] § 872.6770 Cartridge syringe. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71813, Dec. 30, 2019] § 872.6855 Manual toothbrush. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, 2001; 90 FR 55984, Dec. 4, 2025] § 872.6865 Powered toothbrush. (a) Identification. (b) Classification. [55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, 2001] § 872.6866 Radiofrequency toothbrush. (a) Identification. (b) Classification. (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested, and detailed protocols must be provided for each test conducted: (i) Validation of the radiofrequency performance specifications including output power, voltage output, radiofrequency, pulse cycle, waveform, and pulse duration; (ii) Temperature performance testing to evaluate the temperature change of the device, structures of the oral cavity (including skin, tissue, and dental restorations), and toothpaste under worst-case conditions; (iii) An assessment of mechanical output specifications and physical properties including vibration frequency, tuft retention, brush head strength, and battery voltage; and (iv) Use life and durability testing. (2) A label comprehension and self-selection study must demonstrate that the intended user population can understand the package labeling and correctly choose the device for the indicated use. (3) Usability performance evaluation must demonstrate that the user can safely and correctly use the device, based solely on reading the directions for use. (4) The patient-contacting components of the device must be demonstrated to be biocompatible. (5) Electrical safety, thermal safety, mechanical safety, battery safety, and electromagnetic compatibility (EMC) testing must be performed. (6) Software verification, validation, and hazard analysis must be performed. (7) Labeling must include: (i) Information on how the device operates, including images or illustrations; (ii) A detailed summary of the device technical specifications; (iii) A warning which states that the use of this device is not a substitute for regular visits to a dentist for routine clinical care; (iv) Instructions on how to clean and maintain the device; and (v) The use life and disposal of the components of the device. [89 FR 72321, Sept. 5, 2024] § 872.6870 Disposable fluoride tray. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, 2001; 90 FR 55985, Dec. 4, 2025] § 872.6880 Preformed impression tray. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13832, Apr. 5, 1989; 66 FR 38800, July 25, 2001; 90 FR 55985, Dec. 4, 2025] § 872.6890 Intraoral dental wax. (a) Identification. (b) Classification. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, 2001; 90 FR 55985, Dec. 4, 2025]