872.6870 Disposable fluoride tray. 872.6880 Preformed impression tray. 872.6890 Intraoral dental wax.

AUTHORITY: 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.

a pre

(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 market 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 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 substan

tially 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:

(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. 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.

194-069 D-01--11

(a) Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.

(b) Classification. Class II, subject to the following special controls:

(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 sys. tem.

(a) Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth. jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

(b) Classification. Class II.

§ 872.1810 Intraoral source x-ray system.

(a) Identification. An intraoral source x-ray system is an electrically powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The xray source (a tube) is located inside the mouth. This generic type of device may include patient and equipment supports and component parts.

(b) Classification. Class II.

§ 872.1820 Dental x-ray exposure alignment device.

(a) Identification. A dental x-ray exposure alignment device is a device intended to position x-ray film and to align the examination site with the xray beam.

(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 63008, Dec. 7, 1994]

§ 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 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]

(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]

§ 872.1870 Sulfide detection device.

(a) Identification. A sulfide detection device is a device consisting of an ACpowered control unit, probe handle, probe tips, cables, and accessories. This device is intended to be used in vivo, to manually measure periodontal pocket probing depths, detect the presence or absence of bleeding on probing, and detect the presence of sulfides in periodontal pockets, as an adjunct in the diagnosis of periodontal diseases in adult patients.

(b) Classification. Class II (special controls) prescription use in accordance with §801.109 of this chapter; conformance with recognized standards of biocompatibility, electrical safety, and sterility; clinical and analytical performance testing, and proper labeling. [63 FR 59717, Nov. 5, 1998]

§ 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 use are mixtures of metals, the major components of which are gold, silver, or palladium. They also may contain a small quantity of copper or platinum. The device is intended to fabricate dental appliances, such as crowns and bridges, for patients. (b) Classification. Class II

§ 872.3080 Mercury and alloy dispenser.

(a) Identification. A mercury and alloy dispenser is a device with a spring-activated valve intended to measure and dispense into a mixing capsule a predetermined amount of dental mercury in droplet form and a premeasured amount of alloy pellets.

(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]

§ 872.3100 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 intended to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth.

(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 63008, Dec. 7, 1994]

§ 872.3140 Resin applicator.

(a) Identification. A resin applicator is a brushlike device intended for use in spreading dental resin on a tooth during application of tooth shade material.

(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]

§ 872.3150 Articulator.

(a) Identification. An articulator is a mechanical device intended to simulate movements of a patient's upper and lower jaws. Plaster casts of the patient's teeth and gums are placed in the device to reproduce the occlusion (bite) and articulation of the patient's jaws. An articulator is intended to fit dentures or provide orthodontic treatment.

(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]

$872.3165 Precision attachment.

(a) Identification. A precision attachment or preformed bar is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture.