21 CFR § 872.1850 Dental Devices

§ 872.1850 Lead-lined position indicator.

Current through Sep 8, 2026 · Read all of Part 872

(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]

← § 872.1840 Dental x-ray position indicating device.§ 872.1870 Sulfide detection device. →