Dura-Crown— 510(k) K261356
Substantially EquivalentHangzhou SHINING3D Dental Technology Co., Ltd.
FDA 510(k) clearance K261356 for Dura-Crown, Substantially Equivalent on 2026-04-27. Applicant: Hangzhou SHINING3D Dental Technology Co., Ltd.. Device class: 2.
Summary
Dura-Crown, from Hangzhou SHINING3D Dental Technology, is filed under product code EBF (Material, Tooth Shade, Resin). The record doesn't describe the material beyond its name and that code name.
Class II, 21 CFR 872.3690. Dental is both the classification panel and the review panel, and it came in as a Special 510(k).
Hangzhou SHINING3D Dental Technology filed from Hangzhou, China. The decision came 3 calendar days after FDA received it (April 24 to April 27, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- Hangzhou SHINING3D Dental Technology Co., Ltd.
- Product code
- Product code EBF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hangzhou, CN
Recent devices under product code EBF
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