510(k) K253053 ยท EBF Material, Tooth Shade, Resin
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
| Applicant | Hangzhou SHINING3D Dental Technology Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Sep 23, 2025 |
| Received | Sep 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253053
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.