21 CFR 872.5500

§ 872.5500 Extraoral orthodontic headgear.

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

Cite this

Citation: 21 CFR 872.5500, § 872.5500 Extraoral orthodontic headgear, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90147
Permanent ID: ys:prov:90147@1
SHA-256: 779575a04748c5cf0b782b0d870d8b923b52503aa6510e74199cf13048127943

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Full text

(a) Identification. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth. (b) Classification. Class II.

Legislative history

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