[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR872.1905]

[Page 339-340]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 872_DENTAL DEVICES--Table of Contents
 
                      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 Sec. 872.9. If the device is 
not labeled or otherwise represented as sterile, it is also exempt from 
the current good manufacturing practice regulations in part 820 of this 
chapter, with the exceptions of Sec. 820.180, with respect to general 
requirements concerning records, and

[[Page 340]]

Sec. 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]