ID LIGHT CURE SYSTEM

The ID Light Cure System is a light-curing resin-based coating material for dental use that forms a protective film on dental restorations and prosthetic appliances to enhance surface smoothness and wear resistance. It is indicated for use on crowns, bridges, veneers, inlays, onlays, dentures, orthodontic appliances, and splints, available in 51 shades.

The device has identical technical characteristics to the predicate: resin-based composition cured by photopolymerization; materials applied to restoration surfaces; operates by using photopolymer light irradiation at specific wavelengths to harden the coating layer; no added substances that specifically induce toxicity or significantly different elemental composition compared to the predicate OPTIGLAZE COLOR.

ISO 10993-1:2018 and ISO 7405:2018 for biological safety testing, including cytotoxicity, skin sensitization, oral mucosa irritation, and acute systemic toxicity endpoints. Performance testing conducted per internal protocols and relevant standards including appearance, weight, packaging integrity, color stability, sensitivity to ambient light, and depth of cure.

The device is substantially equivalent because it shares identical indications for use, same design principle (materials applied to surfaces), same material composition and chemical mechanism (resin-based photopolymerization), and same energy source (specific wavelength light curing) as the predicate OPTIGLAZE COLOR. Biological safety testing confirmed no cytotoxic, sensitization, or systemic toxic reactions, and all performance characteristics met specifications without significant differences in mechanism of action or intended purpose.