872.6710 Boiling water sterilizer. 872.6870 Disposable fluoride tray. AUTHORITY: Secs. 501, 510, 513, 515, 520, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 371). SOURCE: 52 FR 30097, Aug. 12, 1987, unless otherwise noted. 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. § 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 com pleted 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 Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices within that generic type. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I 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 its intended use before May 28, 1976, or the device is intended for a use different from the intended use of a preamendments device to which it had been determined to be substantially equivalent; 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; or (b) The modified device operates using a different fundamental scientific technology than that in use in the device before May 28, 1976; 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 in Subpart B-Diagnostic Devices § 872.1500 Gingival fluid measurer. (a) Identification. A gingival fluid measurer is a gauge device intended to measure the amount of fluid in the gingival sulcus (depression between the tooth and gums) to determine if there is a gingivitis condition. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63007, Dec. 7, 1994] § 872.1720 Pulp tester. (a) Identification. A pulp tester is an AC or battery powered device intended to evaluate the pulpal vitality of teeth by employing high frequency current transmitted by an electrode to stimulate the nerve tissue in the dental pulp. (b) Classification. Class II. § 872.1730 Electrode gel for pulp test ers. (a) Identification. An electrode gel for pulp testers is a device intended to be applied to the surface of a tooth before use of a pulp tester to aid conduction of electrical current (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989] §872.1740 Caries detection device. (a) Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current. (b) Classification. Class II. $ 872.1800 Extraoral source x-ray system. (a) Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended § 872.1830 Cephalometer. (a) Identification. A cephalometer is a device used in dentistry during x-ray procedures. The device is intended to place and to hold a patient's head in a standard position during dental x-rays. (b) Classification. Class II. § 872.1840 Dental x-ray position indicating device. (a) Identification. A dental x-ray position indicating device is a device, such as a collimator, cone, or aperture, that is used in dental radiographic examination. The device is intended to align the examination site with the x-ray beam and to restrict the dimensions of the dental x-ray field by limiting the size of the primary x-ray beam. (b) Classification. Class I. The device is exempt from the premarket notifica tion procedures in subpart E of part 807 of this chapter. [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996] § 872.1850 Lead-lined position indicator. (a) Identification. A lead-lined position indicator is a cone-shaped device lined with lead that is attached to a dental x-ray tube and intended to aid in positioning the tube, to prevent the misfocusing of the x-rays by absorbing divergent radiation, and to prevent leakage of radiation. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996] §872.1905 Dental x-ray film holder. (a) Identification. A dental x-ray film holder is a device intended to position and to hold x-ray film inside the mouth. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exceptions of § 820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989] Subpart C-(Reserved) Subpart D-Prosthetic Devices § 872.3050 Amalgam alloy. (a) Identification. An amalgam alloy is a device that consists of a metallic substance intended to be mixed with mercury to form filling material for treatment of dental caries. (b) Classification. Class II. § 872.3060 Gold-based alloys and precious metal alloys for clinical use. (a) Identification. Gold-based alloys and precious metal alloys for clinical § 872.3100 Dental amalgamator. (a) Identification. A dental amalgamator is a device, usually AC-powered, intended to mix, by shaking, amalgam capsules containing mercury and dental alloy particles, such as silver, tin, zinc, and copper. The mixed dental amalgam material is intended for filling dental caries. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63008, Dec. 7, 1994] § 872.3110 Dental amalgam capsule. (a) Identification. A dental amalgam capsule is a container device in which silver alloy is intended to be mixed with mercury to form dental amalgam. (b) Classification. Class I. The device is exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989] § 872.3130 Preformed anchor. (a) Identification. A preformed anchor is a device made of austenitic alloys or alloys containing 75 percent or greater gold or metals of the platinum group |