LumiCera

LumiCera is a liquid photo-curable resin material used with SHINING3D printers to fabricate permanent dental restorations including single crowns, inlays, onlays, veneers, and bridges. The material undergoes free radical polymerization triggered by photoinitiator when exposed to light during layer-by-layer printing, followed by post-curing in a dedicated device. It is available in five color shades (A1, A2, B1, BL, C2) and intended exclusively for professional dental use.

Both LumiCera and predicate FREEPRINT® crown are photo-curable polymer resins composed of methacrylate polymer resin with photoinitiator and pigments. Both use similar light-curing technology (365–405 nm wavelength range) and require CAD/CAM systems. The primary difference is LumiCera offers a narrower shade range (5 shades vs. 8 shades in predicate) and is specific to SHINING3D printers, but both achieve comparable mechanical and physical properties.

ISO 4049 (Dentistry—Polymer-based restorative materials), ISO 10477 (Dentistry—Polymer-based crown and veneering materials), ISO 10993-1 (Biocompatibility evaluation), and ISO 7405 (Dental materials—testing of intra-oral devices). Biocompatibility testing included cytotoxicity, sensitization, oral mucosa irritation, intracutaneous reactivity, acute and subchronic systemic toxicity, implantation, pyrogen, and genotoxicity tests.

LumiCera is substantially equivalent because it has the same intended use (fabricating permanent dental restorations), same material composition (methacrylate polymer resin with photoinitiator and pigments), same curing technology (photo-curable), and meets identical performance and biocompatibility standards as the predicate FREEPRINT® crown. Minor differences in shade options and printer compatibility do not raise new safety or effectiveness concerns, and performance data confirm equivalent safety and effectiveness.