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21 CFR 872.3630

§ 872.3630 Endosseous dental implant abutment.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 872.3630, § 872.3630 Endosseous dental implant abutment, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90096
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(a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. (b) Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.