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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR872.5550]
See Related Information on Teething ring. in CDRH databases



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

Sec. 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 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]

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