510(k) K102308 ยท DZE Implant, Endosseous, Root-Form
SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS
| Applicant | Dentium Co., Ltd., Cypress CA, US |
| Decision | Substantially Equivalent, Nov 22, 2010 |
| Received | Aug 16, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102308
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.