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Code · CFR · Title 21 — Food and Drugs · Part 872 — Dental Devices · § 872.1850

§ 872.1850. Lead-lined position indicator.

98 words·~1 min read·/us/cfr/t21/s§ 872.1850·

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(a)Identification. A lead-lined position indicator is a cone-shaped device lined with lead that is attached to a dental x-ray tube and intended to aid in positioning the tube, to prevent the misfocusing of the x-rays by absorbing divergent radiation, and to prevent leakage of radiation.
(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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