510(k) K253334 ยท DZE Implant, Endosseous, Root-Form
ZENEX Implant System_Short (R-System)
| Applicant | Izenimplant Co., Ltd., Pyeongtaek-Si, KR |
| Decision | Substantially Equivalent, Mar 16, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253334
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.