DentaTOOTH

DentaTOOTH is a 3D printer resin used by dental professionals to manufacture temporary dental restorations including crowns, bridges, inlays, onlays, and veneers. It is a light-cure methacrylate-based resin available in six Vita shades and has a 36-month shelf life.

DentaTOOTH is a Type 2, Class 2 resin per ISO 10477:2020 and Type 1, Class 2, Group 2 resin per ISO 4049:2019. It is formulated as a methacrylate-based resin with photoinitiator, UV absorber, dispersant and pigments, designed for use with Asiga Max and Pro Series 3D printers at 385nm wavelengths. Material formulation differs from predicates, though all devices use the same type of equipment (scanner, design software, DLP-based printer, post-curing unit).

ISO 10477:2020 Dentistry — Polymer-based crown and veneering materials; ISO 4049:2019 Dentistry — Polymer-based restorative materials; ASTM D4169-22/14-576 for packaging validation; ISO 10993-1:2018/2-258 for biocompatibility.

DentaTOOTH is substantially equivalent because it has identical classification, regulation number, product code (EBG), prescription status, and indications for use as the predicates (E-Temp K211101 and P pro Crown & Bridge K200039). Performance testing demonstrates equivalent safety and efficacy with no new questions raised. Although material formulation differs, all three devices serve the same function in the same clinical application using comparable manufacturing equipment and processes.