21 C.F.R. § 872.1905 Dental x-ray film holder.
Title 21 - Food and Drugs
(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 regulations 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]
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart B—Diagnostic Devices
§ 872.1905 Dental x-ray film holder.
