21 C.F.R. § 872.1840 Dental x-ray position indicating device.
Title 21 - Food and Drugs
(a) Identification. A dental x-ray position indicating device is a device, such as a collimator, cone, or aperture, that is used in dental radiographic examination. The device is intended to align the examination site with the x-ray beam and to restrict the dimensions of the dental x-ray field by limiting the size of the primary x-ray beam. (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. [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38797, July 25, 2001]
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart B—Diagnostic Devices
§ 872.1840 Dental x-ray position indicating device.
