Title 21 Part 872 → Subpart B → §872.1745

Title 21 → Chapter I → Subchapter H → Part 872 → Subpart B → §872.1745

Electronic Code of Federal Regulations e-CFR

Title 21 Part 872 → Subpart B → §872.1745

e-CFR data is current as of January 27, 2020

Title 21Chapter ISubchapter HPart 872Subpart B → §872.1745

Title 21: Food and Drugs
Subpart B—Diagnostic Devices

§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 §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]