Reon

Reon is a photopolymerizable, methacrylate-based composite resin used in dental CAD/CAM 3D printing technology to fabricate both temporary and permanent dental restorations, including crowns, bridges, inlays, onlays, and veneers. The liquid resin is stored in aluminum bottles in four shade options (Clear, A1, A2, A3) and is cured using a 405nm UV laser with DLP-based 3D printers.

Reon uses methacrylate-based resin with photoinitiator, inhibitor, and pigments in pre-mixed liquid form, identical to the predicate Tera Harz II. Both devices employ additive manufacturing via DLP 3D printers with 50 μm layer thickness and 40–90 μm XY resolution. The proposed device is compatible with UV-curing 3D printers and requires post-curing for final polymerization, matching the predicate's mechanism and manufacturing approach.

ISO 10993 series (parts 1, 3, 5, 6, 10, 11) for biocompatibility evaluation; ISO 10477:2020 for polymer-based crown and veneering materials performance (depth of cure, flexural strength, water sorption, and solubility). Testing also followed FDA guidance on technical considerations for additive manufactured medical devices.

Reon and Tera Harz II share identical indications for use, mechanism of action (photopolymerizable resin cured layer-by-layer with UV light), manufacturing technology (additive), material composition (methacrylate-based), product state (pre-mixed liquid), biocompatibility standards, and performance test requirements. Performance metrics (flexural strength 119.0 vs 125.5 MPa, depth of cure 90.0% vs 91.3%, water sorption 11.0 vs 22.03 μg/mm³) fall within acceptable variability with no safety or efficacy concerns, confirming substantial equivalence under 21 CFR 872.3690.