510(k) K161103 ยท DZE Implant, Endosseous, Root-Form
US SA Implant System
| Applicant | Osstem Implant Co., Ltd., Busan, KR |
| Decision | Substantially Equivalent, Feb 2, 2017 |
| Received | Apr 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161103
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.