21 CFR 872.3580
§ 872.3580 Preformed gold denture tooth.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 872.3580, § 872.3580 Preformed gold denture tooth, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90093
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Full text
(a) Identification. A preformed gold denture tooth is a device composed of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use as a tooth or a portion of a tooth in a fixed or removable partial denture.
(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.