[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR872.1850]

[Page 324-325]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 872--DENTAL DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 872.1850  Lead-lined position indicator.

    (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

[[Page 325]]

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 Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38797, July 25, 2001]