510(k) K161604 ยท DZE Implant, Endosseous, Root-Form
OSSTEM Implant System
| Applicant | Osstem Implant Co., Ltd., Busan, KR |
| Decision | Substantially Equivalent, Oct 17, 2016 |
| Received | Jun 10, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161604
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.