21 CFR 872.3130
§ 872.3130 Preformed anchor.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 872.3130, § 872.3130 Preformed anchor, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90065
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Full text
(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 (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.