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Title 21 → Chapter I → Subchapter H → Part 872 → Subpart B → §872.1840

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Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart B—Diagnostic Devices

§872.1840 Dental x-ray position indicating device.

(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]

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