Regulation 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.
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.