Midas Restore

Midas Restore is a light-curable polymerizable resin material used with a 3D printer to fabricate dental prosthetics in various VITA-matched shades. It is intended for fabrication of crowns, partial crowns (inlays, onlays), veneers, and artificial teeth for removable dentures in dental offices and laboratories as an alternative to traditional restorative materials.

Both the subject device and predicate (Digital Crown) are acrylate resins cured by light-based technology and used with 3D printers relying on scanned patient images to produce dental appliances. The primary technological difference is in the acrylate resin material composition, though both undergo curing prior to final trimming and cleaning.

ISO 10993-1, -3, -5, -10, -11, -23 (biocompatibility); ISO 10477 (dental prosthesis material testing including flexural strength, sorption, solubility, surface finish, bond strength); ISO 4049 (radio opacity); ISO 20795-1 (free monomer extraction); ISO 7405 (oral biocompatibility).

Midas Restore is substantially equivalent because it has the same intended use, indications, and similar technological characteristics as the predicate Digital Crown device. Performance data demonstrate comparable safety and effectiveness across all critical parameters (flexural strength, sorption, solubility, biocompatibility, accuracy). Minor material composition differences raise no new safety or effectiveness issues.