Additive Manufacturing (Light Curing) Crown Bridge Resin

EZPRINT CERAMIC CROWN is a light-cured dental resin for 3D printing of permanent single crowns, denture teeth, inlays, onlays, veneers, and implant crowns in anterior and posterior regions. It is also used for long-term provisional crowns and bridges. The material is composed of methacrylic acid esters, inorganic fillers, photoinitiators, and pigments, packaged in HDPE bottles in multiple tooth-shade colors.

The device uses DLP 3D printer technology with visible light wavelengths at 385nm or 405nm plus post-curing, compared to the predicate which uses 385nm only. The subject device offers more shade variations (20 shades vs. 8 standard VITA shades) and a 3-year shelf life versus the predicate's 2 years. Flexural strength specification is ≥50 MPa versus the predicate's ≥100 MPa, though actual test results exceed 100 MPa. All other technological characteristics—materials composition, equipment requirements, performance testing standards, and biocompatibility—are substantially similar.

ISO 4049:2019 (Dentistry – Polymer-based restorative materials), ISO 10477:2020 (Dentistry – Polymer-based crown and veneering materials), ISO 10993-1:2018 and ISO 7405:2018 (Biocompatibility testing including cytotoxicity, sensitization, irritation, acute and subchronic toxicity, genotoxicity, and implantation).

The device shares the same intended use, classification, and fundamental technology (light-cured 3D resin printing for dental restorations) as the predicate. Although the wavelength range is slightly broader (385–405nm vs. 385nm only), both utilize identical polymerization mechanisms and meet the same ISO performance standards. The wider shade range and longer shelf life do not raise safety or effectiveness concerns. The lower specified flexural strength (≥50 MPa) meets ISO 10477:2020 minimum standards, and actual test results consistently exceed 100 MPa, matching predicate performance. Biocompatibility, sterility, and all critical material properties are equivalent.