Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)

Dura-Crown is a liquid photocurable resin material used in combination with a SHINING3D 3D printer to fabricate dental restorations. It is indicated for both anterior and posterior indirect restorations including inlays, onlays, veneers, full crowns, bridge restorations, artificial teeth, and temporary crowns and bridges. The material is stored in 500ml HDPE bottles and undergoes layer-by-layer light curing during printing followed by post-curing in a dedicated cure device.

Dura-Crown is a methacrylate-based polymer resin produced by free radical polymerization of oligomers triggered by a photoinitiator, with fillers, additives, and pigments. It comes in four VITA-shade colors (A1, A2, A3, B1) and is non-sterile with a 2-year shelf life. The material has a flexural strength specification of ≥120 MPa compared to the predicate's ≥100 MPa. Both devices use UV light curing and require validated 3D-printer and post-curing equipment.

ISO 4049:2019 (Dentistry – Polymer-based restorative materials), ISO 10477:2020 (Dentistry – Polymer-based crown and veneering materials), ISO 22112:2017 (Dentistry – Artificial teeth for dental prostheses), ISO 10993-1:2018 and ISO 7405:2018 for biocompatibility, and ASTM F1980-21 for shelf-life testing.

The subject device shares identical indications for use, material type (methacrylate-based polymer), material shades, curing methodology, and performance standard requirements as the predicate device VarseoSmile TriniQ (K233596). Both are Class II tooth shade resin materials with the same product codes (EBF, EBG, PZY) and both employ the same equipment framework (validated 3D-printer and post-cure device). Minor differences in shelf life (2 vs. 3 years) and flexural strength specification (≥120 vs. ≥100 MPa) are not safety or performance concerns; the subject device's higher flexural strength and comprehensive biocompatibility testing actually exceed predicate requirements. The chemical composition is similar (oligomers, photoinitiator, fillers, additives, and pigments), and both demonstrate equivalent performance against the same ISO standards.