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e-CFR data is current as of February 24, 2021

Title 21Chapter ISubchapter HPart 872Subpart F → §872.5500


Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart F—Therapeutic Devices


§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.

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