510(k) K063861 ยท DZE Implant, Endosseous, Root-Form
GS SYSTEM
| Applicant | Osstem Implant Co., Ltd., Dunwoody GA, US |
| Decision | Substantially Equivalent, Sep 21, 2007 |
| Received | Dec 28, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063861
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.