LED Curing Light (C01-X, C02-X)

The LED Curing Light (C01-X, C02-X) is a dental device that uses blue LED technology to cure (harden) dental resins and composites. It is intended for use only by trained dental professionals and offers multiple curing modes to provide flexibility in polymerizing dental materials.

Both the subject device and predicate device are LED curing lights for dental composites or resins with substantially equivalent indications for use and technological characteristics. The minor differences between them do not constitute a new intended use or raise different safety and effectiveness issues compared to the predicate devices.

ISO 10650 (radiant power output), IEC 60601-1 and IEC 60601-2-60 (electrical safety), and IEC 60601-1-2 and IEC 60601-4-2 (electromagnetic compatibility). Testing also included heat generation and depth of cure evaluation.

The subject device and its primary predicate (Premium Plus C01/C02 LED Curing Light, K153514) are both LED-based curing lights with identical indications for use in light curing dental resins and composites. Performance testing demonstrated that the subject device meets the same safety and effectiveness standards through radiant power output, electrical safety, and EMC testing. The minor technological differences do not raise new safety or effectiveness concerns, making the device substantially equivalent.