FDAnews Device Daily Bulletin


April 7, 2006

The FDA has released a premarket 510(k) notification guidance on dental curing lights used for photo activation of resins and dental bleaching agents.

Classified under the "Ultraviolet Activator for Polymerization" regulation, these devices produce ultraviolet radiation intended to set resinous dental pit and fissure sealants or restorative materials. The scope of the guidance includes devices that use light sources such as quartz-tungsten halogen lamps, light-emitting diodes and xenon-plasma arcs, as well as laser energy sources.

The FDA recommends that companies show how the new device is both similar and different from already marketed devices and include side-by-side comparisons, if possible.

The FDA has identified the risks generally associated with the use of dental curing lights in the guidance and addresses the measures recommended to mitigate those risks, which could include ineffective treatment, thermal, optical or electrical injury, electromagnetic interference, cross-contamination and improper use.

For more information, access the guidance at http://www.fda.gov/cdrh/ode/guidance/1591.html (http://www.fda.gov/cdrh/ode/guidance/1591.html).