Title 21: Food and Drugs
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/ PART 872 - DENTAL DEVICES
/ Subpart F - Therapeutic Devices / § 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.