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Source of illumination for curing dental restorative materials.

The Nova-Pulse cordless battery operated hand-held light is a cordless curing light using light emitting diodes. No filters are required to bloc out harmful and unnecessary rays. The light produced by these diodes is specifically in the optimum curing range of 10 to 500 nanometers

This document is a 510(k) summary for the Nova-Pulse Cordless Curing Light, which is a dental device used for curing restorative materials. This type of device, which is an ultraviolet activator for polymerization, typically undergoes performance testing related to its output wavelength, intensity, and ability to effectively cure dental materials. However, the provided text does not contain any information about acceptance criteria, device performance results, or any studies conducted to prove the device meets specific criteria.

The document primarily covers:

• General administrative information about the 510(k) submission.
• A brief description of the device (cordless, LED-based, optimal curing range of 10 to 500 nanometers).
• Its intended use (source of illumination for curing dental restorative materials).
• The FDA's letter of clearance, stating that the device is substantially equivalent to a legally marketed predicate device (K000393 – Nova Cordless™ Curing Light).

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, rather than detailed performance study results.

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