A. It is a device that produces ultraviolet light intended to polymerize or take off resinous dental pit and fissure sealants or restorative material by transmission of light through a rod.

The scope of this guidance includes devices that use light sources such as quarts-tungsten-halogen lamps, light emitting diodes (LED's), and xenon-plasma arcs, as well as laser energy sources.

RULE: The FDA guidance does not include heat or light sources intended exclusively for tooth bleaching procedures. These are classified under 2CFR 872.6475, Heat Source for Bleaching Teeth, product code EEG. These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations of 872.9. (This action being considered cosmetic.)

A. It is very important to understand that Congress passes the laws that govern the United States. To put those laws into effect, Congress authorizes certain government agencies, including the FDA to create and enforce the rules and regulations, but only those as authorized under the law. A change in FDA's statutory authority over cosmetics would require a full congressional vote. (It would take an act of Congress.)

Additional information is also available at (FD&C Act, sec. 201(i)).
21 CFR 872.6070 Ultraviolet Activator for Polymerization