21 CFR 872.3360
§ 872.3360 Preformed cusp.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 872.3360, § 872.3360 Preformed cusp, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90080
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.