Bluemoon

The Bluemoon is a dental curing light device that polymerizes resinous dental materials, restorative composite materials, and orthodontic brackets using visible light in the 385-515nm wavelength range. It offers four operational modes (Hyper, Turbo, Low, and Soft Start) with varying output intensities and irradiation times for dental applications.

The Bluemoon features dual peak wavelengths at 410nm and 460nm (versus predicate's 405nm and 460nm), four operational modes with outputs ranging from 1200-3000mW/cm², a 3.7V lithium-ion battery with 5V charger, and an LED light source. It is a cordless pen-style device with a built-in battery, compared to the predicate D-Lux+ which has external battery and charger configuration.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 62133-2 (battery), ISO 10993-1/5/10/23 (biocompatibility including cytotoxicity, skin sensitization, and intracutaneous reactivity), and FDA guidance performance test requirements.

Although the Bluemoon differs from the predicate D-Lux+ in peak wavelength (410nm vs 405nm), operational modes, battery specifications, and design configuration, gap analysis demonstrates these differences do not affect safety or efficacy. The similar dual-peak wavelengths, comparable light output ranges, identical LED technology and safety standards, plus biocompatibility and performance testing confirming specifications like ≥80MPa polymerization strength and ≥2.0mm depth of cure, establish substantial equivalence in intended use and function.