Electronic Code of Federal Regulations
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e-CFR data is current as of March 2, 2021 |
Title 21 → Chapter I → Subchapter H → Part 872 → Subpart D → §872.3360 |
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart D—Prosthetic Devices
§872.3360 Preformed cusp.
(a) Identification. A performed cusp is a prefabricated device made of plastic or austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be used as a temporary cusp (a projection on the chewing surface of a tooth) to achieve occlusal harmony (a proper bite) before permanent restoration of a tooth.
(b) Classification. Class I (general controls). 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 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001]