(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 § 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.