FDAnews Device Daily Bulletin


March 31, 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. These devices are classified under the "Ultraviolet Activator for Polymerization" regulation, which is a device that produces ultraviolet radiation intended to set resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.

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 guidance does not relate to heat and light sources intended exclusively for tooth bleaching procedures. These devices are exempt for the premarket notification procedures.

The FDA recommends that companies show how the new device is both similar and different from already marketed devices, including 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 the risks.

These risks 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).