Hangzhou SHINING3D Dental Technology Co., Ltd. · Class II · Cleared Apr 27, 2026
| K-number | K261356 |
| Device name | Dura-Crown |
| Applicant | Hangzhou SHINING3D Dental Technology Co., Ltd. |
| Product code | EBF |
| Device class | Class II |
| Decision date | Apr 27, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 872.3690 |
Dura-Crown is a liquid photo-curable resin material used with 3D printers 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 cured using UV light and is intended exclusively for professional dental use.
The device is a methacrylate-based polymer resin composed of (meth)acrylate oligomers and monomers, photoinitiator, fillers, additives, and pigments. The subject device introduces a new 'Nano' specification with different packaging configurations (5g, 8g, 26g cartridges) and qualifies a new supporting 3D printer (Ceramix-Nano) in addition to the previously qualified AccuFab-D1s/C1s printer with FabCure2 post-curing unit. The core material formulation, curing properties, and chemical composition remain unchanged.
ISO 4049:2019, ISO 10477:2020, ISO 22112:2017, ISO 10993-1:2018, ISO 7405:2018, and ISO 14971 (risk analysis). Testing confirms flexural strength ≥120 MPa and biocompatibility. Shelf life is 2 years.
View the full FDA submission: accessdata.fda.gov