§872.1850. Lead-lined position indicator.
21 C.F.R. § 872.1850
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.
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.
Notes, amendments, and revision history
Amendments
[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38797, July 25, 2001]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.
Amendments
[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38797, July 25, 2001]