§ 872.1905. Dental x-ray film holder.
127 words·~1 min read·
/us/cfr/t21/s§ 872.1905·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter. [52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001; 90 FR 55983, Dec. 4, 2025]