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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: 21CFR872.1905]
See Related Information on Dental x-ray film holder. 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 B--Diagnostic Devices

Sec. 872.1905 Dental x-ray film holder.

(a) Identification. A dental x-ray film holder is a device intended to position and to hold x-ray film inside the mouth.

(b) Classification. Class I (general controls). 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. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exceptions of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001]

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