510(k) K252585 ยท DZE Implant, Endosseous, Root-Form
ZENEX Implant System_R-System
| Applicant | Izenimplant Co., Ltd., Pyeongtaek-Si, KR |
| Decision | Substantially Equivalent, Jan 8, 2026 |
| Received | Aug 15, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252585
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.