Hangzhou SHINING3D Dental Technology Co., Ltd. · Class II · Cleared Apr 17, 2026
| K-number | K261261 |
| Device name | Dura-Arch |
| Applicant | Hangzhou SHINING3D Dental Technology Co., Ltd. |
| Product code | EBG |
| Device class | Class II |
| Decision date | Apr 17, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 872.3770 |
Dura-Arch is a liquid photo-curable resin used with SHINING3D 3D printers to fabricate temporary dental restorations and preformed denture teeth. The resin undergoes free radical polymerization triggered by light exposure during layer-by-layer printing, followed by post-curing.
The device is a methacrylate-based acrylic resin for extra-oral light curing, using additive manufacturing and UV curing methods. Key differences from the predicate (GR-17) include lower flexural strength (≥50 MPa vs. ≥100 MPa) but identical water sorption and solubility limits. Both devices use identical equipment, shelf-life (2 years), and are non-sterile liquids.
ISO 4049:2019 (polymer-based restorative materials), ISO 10477:2020 (polymer-based crown materials), ISO 22112:2017 (artificial teeth), ISO 10993-1:2018 and ISO 7405:2018 (biocompatibility), and ASTM F1980-21 (shelf-life).
The subject device shares identical intended use, regulatory classification (Class II, 21 CFR 872.3770), manufacturing method (additive), curing method (UV light), and performance testing standards with the GR-17 predicate. Minor differences in flexural strength and chemical formulation do not raise additional safety concerns based on comprehensive biocompatibility and bench testing demonstrating equivalent safety and effectiveness.
View the full FDA submission: accessdata.fda.gov