Code of Federal Regulations · Section
§ 872.1820 — Dental X-ray Exposure Alignment Device
21 C.F.R. § 872.1820
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(a) Identification. A dental x-ray exposure alignment device is a device intended to position x-ray film and to align the examination site with the 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.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351