510(k) K052968 ยท DZE Implant, Endosseous, Root-Form
MODIFICATION TO: ORLUS MINI SCREW
| Applicant | Ortholution Co., Ltd., Dunwoody GA, US |
| Decision | Substantially Equivalent, Sep 8, 2006 |
| Received | Oct 21, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052968
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.