GLOSSY COAT (15ML)

GLOSSY COAT is a light-cured surface coating material applied to resin-based dental prostheses such as crowns, bridges, and dentures to improve surface smoothness and wear resistance. It can be applied in the oral cavity or on a working model and is cured using an LED light source.

GLOSSY COAT is a liquid formulation containing multifunctional acrylate, methylmethacrylate, silica filler, and photoinitiator. It has a hardness above 18Hv0.2, viscosity between 7–25 mPa·s, and cures in 3 minutes with LED light (365–410 nm wavelength) or 20 seconds with chairside LED. The predicate device OPTIGLAZE COLOR has similar composition and physical properties but includes pigment and accepts multiple curing light types (LED, halogen, plasma arc).

ISO 10993-1:2025 for biocompatibility assessment including cytotoxicity, sensitization, irritation, systemic toxicity, local effects, genotoxicity, and carcinogenicity. ISO 13485 quality management system requirements cited for design controls, nonconforming product handling, and corrective/preventive actions.

GLOSSY COAT is substantially equivalent to the predicate device OPTIGLAZE COLOR (K133836) because both share the same intended use (coating resin-based prostheses for smoothness and wear resistance), same classification (21 CFR 872.3310, product code EBD), similar liquid formulation with comparable main ingredients, and equivalent physical properties (hardness and viscosity). The intended use of GLOSSY COAT is included within the broader intended use of OPTIGLAZE COLOR.