GroundRules
21 CFR 872.5550: Teething ring.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 872—DENTAL DEVICES
- Subpart F—Therapeutic Devices
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON