510(k) K253493 ยท DZE Implant, Endosseous, Root-Form
Dentis SQ-SL AXEL Fixture
| Applicant | Dentis Co., Ltd., Dalseo-Gu, KR |
| Decision | Substantially Equivalent, Mar 4, 2026 |
| Received | Oct 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253493
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.