Grandio disc multicolor

Grandio disc multicolor is a nano-hybrid composite CAD/CAM disc containing 86% inorganic fillers used to manufacture customized permanent dental restorations including crowns, inlays, onlays, veneers, implant-retained crowns, and 3-unit bridges in anterior and posterior regions. It is indicated for patients with lack of tooth substance, partial edentulism, or complete edentulism.

The device is a polymer resin/ceramic hybrid composite disc with a methacrylate-based resin matrix (14.44% EtoBG, UDMA, BisGMA, TEGDMA) and 86% inorganic silica-based glass and silica fillers. It demonstrates flexural strength of 315.9 MPa, modulus of elasticity of 12.95 GPa, compressive strength of 524.06 MPa, and water absorption of 14.67 µg/mm³. The device is non-sterile and intended for single-patient, multiple-use applications.

ISO 4049 (Dentistry – Polymer-based Restorative Materials), ISO 7405 (Dentistry – Evaluation of biocompatibility of medical devices used in dentistry), ISO 10993-1 (Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process), and EN ISO 10477 (water absorption and solubility testing).

Grandio disc multicolor is substantially equivalent to the predicate device AMBARINO® High-Class because both are CAD/CAM polymer resin/ceramic hybrid composite discs with similar indications for use, physical attributes, and manufacturing methods. All performance testing shows the subject device meets or exceeds minimum standards with results substantially equivalent to the predicate, and any minor differences in materials composition (such as resin matrix or filler content) have been successfully evaluated through comprehensive biocompatibility and performance testing demonstrating equivalent safety and effectiveness.