510(k) K260370 ยท EIH Powder, Porcelain
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
| Applicant | Bloomden Bioceramics (HuNan) Co., Ltd., Changsha, CN |
| Decision | Substantially Equivalent, Mar 30, 2026 |
| Received | Feb 5, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260370
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.