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872.5550—Teething ring.

(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.

(a) Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.

(b) (1) Classification. Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

(2) Class II if the teething ring contains a fluid, such as water.

Code of Federal Regulations

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994]

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