Biomic Color Opaque

Biomic Color Opaque is a liquid coloring agent composed of methylacryloyl propyl trimethoxy silane, deionized water, 1,3-butanediol, and various metal nitrates. It is used by dental technicians to color pre-sintered zirconia dental restorations by immersion or brushing before high-temperature sintering, applied to the internal surface of dental prostheses to achieve desired aesthetic shades.

The subject device differs from the predicate in composition (different silane-based formula versus water and polyethylene glycol base), available color options (10 shade variants versus 23 in predicate), and method description (mixing Type I and Type II components in 1:1 ratio versus brush/immerse only). Both are non-sterile liquids in containers, comply with ISO 6872 for physicochemical properties, and are designed for mucosal surface contact exceeding 30 days.

ISO 6872:2015/AMD 1:2018 (Dentistry - Ceramic materials); ISO 10993-1:2018 and ISO 7405:2018 (Biocompatibility); ISO 10993-5, 10993-10, 10993-23, 10993-11, 10993-6, 10993-3, and 10993-18 (specific biocompatibility tests including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogen, implant, mutagenicity, and chemical characterization).

Despite compositional differences and different color shade options, the devices share identical indications for use, product code, regulatory class, and operation principle. Material composition differences do not present safety concerns because the subject device passed comprehensive biocompatibility testing equivalent to the predicate's standards. Color variations are aesthetic only and do not alter fundamental safety, efficacy, or functional performance. The subject device demonstrated compliance with the same physicochemical standards and biocompatibility requirements as the predicate.