LED Curing Lights (DB686 HALO)

The LED Curing Lights (DB686 HALO) is a cordless, pen-style dental device that uses blue and violet LED light (wavelength 385–515 nm) to cure polymer-based restorative dental materials such as composites, cements, and orthodontic adhesives. It is intended for use by qualified dental professionals in hospital, clinic, or office settings.

The device features a 10W LED light source with dual peak wavelengths at 402 nm and 460 nm, maximum light output of approximately 3000 mW/cm² in turbo mode, multiple operational modes (resin curing, orthodontics, caries detection), a rechargeable 3.7V lithium-ion 800 mAh battery, and disposable polypropylene protective sleeves for infection control. It differs from the predicate (K220826) in having higher maximum light intensity and additional operational modes, but these differences do not affect safety or effectiveness.

ISO 10993-5, ISO 10993-10, ISO 10993-11 (biocompatibility); IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60 (electrical safety); IEC 62471 (photobiological safety); ISO 10650 (powered polymerization activators); ANSI/AAMI ES60601-1 and ANSI/AAMI ES60601-1-2 (US national requirements); IEC 62133-2 (lithium battery safety); ISO 4049 (polymer-based restorative materials).

The device is substantially equivalent because it shares the same intended use, principles of operation, and basic design (pen-style cordless handpiece with disposable sleeves) as the primary predicate K220826. Although the proposed device has higher maximum light intensity and additional modes, comparative testing shows these differences do not create new safety risks or affect clinical effectiveness. The device passed all required safety testing and performance standards matching those of predicates, and the functional differences are due to design variations that do not result in different intended use or clinical performance characteristics.