[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR872.1745]

[Page 338]
 
                        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. 872.1745  Laser fluorescence caries detection device.

    (a) Identification. A laser fluorescence caries detection device is 
a laser, a fluorescence detector housed in a dental handpiece, and a 
control console that performs device calibration, as well as variable 
tone emitting and fluorescence measurement functions. The intended use 
of the device is to aid in the detection of tooth decay by measuring 
increased laser induced fluorescence.
    (b) Classification. Class II, subject to the following special 
controls:
    (1) Sale, distribution, and use of this device are restricted to 
prescription use in accordance with Sec. 801.109 of this chapter;
    (2) Premarket notifications must include clinical studies, or other 
relevant information, that demonstrates that the device aids in the 
detection of tooth decay by measuring increased laser induced 
fluorescence; and
    (3) The labeling must include detailed use instructions with 
precautions that urge users to:
    (i) Read and understand all directions before using the device,
    (ii) Store probe tips under proper conditions,
    (iii) Properly sterilize the emitter-detector handpick before each 
use, and
    (iv) Properly maintain and handle the instrument in the specified 
manner and condition.

[65 FR 18235, Apr. 7, 2000]