Light-curing Coloring Materials (ALCM)

Light-curing Coloring Materials (ALCM) is a dental restorative accessory material used for individualized staining of directly placed and laboratory-fabricated acrylic resin restorations, composite resin restorations, and resin-based ceramics. The device is supplied non-sterile in food-grade PE bottles in volumes of 1–10 ml and is available in multiple shades including transparent, brown, blue, white, and various colored options.

The subject device is a light-curing resin liquid for dental surface staining applied chairside or in laboratory settings, using photoinitiator activation for free-radical polymerization. Key differences from the predicate include a broader range of material shades, curing specifications in the 385–405 nm wavelength range (versus predicate's 400–500 nm), and specific intensity and time conditions for chairside and laboratory curing equipment.

ISO 4049 (Dentistry – Polymer-based restorative materials), ISO 20795-1:2013 (Residual monomer testing), ISO 10993-1:2018 (Biocompatibility evaluation), ISO 10993 parts 3, 5, 10, 11, and 23 (Cytotoxicity, sensitization, irritation, systemic toxicity, and specific tests), and ISO 7405:2018 (Biocompatibility of medical devices used in dentistry).

The subject device is substantially equivalent to the predicate (IPS Empress Direct Color, K121230) because both are light-curing resin liquids intended for esthetic characterization of dental restorations with the same fundamental mechanism of light-activated polymerization. Performance testing per ISO 4049:2019 showed no significant differences, and biocompatibility testing meets the same standards; differences in shade options and curing parameters represent variations in acceptable equipment and do not introduce new safety or effectiveness concerns.