21 CFR § 872.5500 - Extraoral orthodontic headgear.

---
identifier: "/us/cfr/t21/s872.5500"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 872.5500 - Extraoral orthodontic headgear."
title_number: 21
title_name: "Food and Drugs"
section_number: "872.5500"
section_name: "Extraoral orthodontic headgear."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "872"
part_name: "DENTAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 30097, Aug. 12, 1987, unless otherwise noted."
cfr_part: "872"
---


# 872.5500 Extraoral orthodontic headgear.

(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.