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