Kimber-White, Inc.

Federal Guidelines:

FDA: Rules, Guidence, Regulations and Classifications

Ultraviolet activator is a divice that produces ultraviolet light to polymerize or take off resinous dental pit and fissure sealants or restorative material by transmission of light through a rod. The scope of the guidance includes devices that use llight sources such as quarts-tungsten-halogen lamps, light emitting diodes (LED's) and xenon-plasma arcs, as well as laser energy sources.

The FDA guidance does not include heat and 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 pre-market notification procedures in subpart E of part 807 of  this chapter, subject to the limitations of 872.9 (This action being considered cosmetic)

A change in the FDA's statutory over cosmetics would require a full congressional vote. Kimber-White is a cosmetic procedure for teeth whitening.

Additional information is also available at (FD&C Act, sec 201(i)).

21 CFR 872.6070 Ultraviolet Activator for Polymerization