21 CFR § 872.5550 - Teething ring.
§ 872.5550 Teething ring.
(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 (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.