visio.lign color, visio.lign shield

visio.lign color and visio.lign shield are light-curing, acrylate-based glossy coatings applied to dental restorations, denture base materials, and artificial teeth. visio.lign color provides characterization with color effects (available in 17 shades), while visio.lign shield provides surface coating and wear resistance. Both products are used by dental professionals in dental laboratories, surgeries, and clinics.

Both the subject device and predicate share the same light-curing mechanism and similar composition. The devices are acrylate-based glossy coatings designed to achieve surface smoothness and color effects on dental materials. biocompatibility was assessed for both devices in accordance with ISO 10993 1:2009.

ISO 10993 1:2009 (biocompatibility assessment). Performance bench testing included Bond strength, Colour stability, Surface roughness, and Viscosity.

The subject devices are substantially equivalent because they share the same curing mechanism, similar acrylate-based composition, and identical intended uses on composite restorations and denture materials as the predicate device (Optiglaze Color). Both achieve surface smoothness and color characterization through the same technological approach. Performance bench testing demonstrated the subject device meets the same design specifications and performance standards as the predicate, with no differences that would raise safety or effectiveness concerns.