510(k) K041368 ยท DZE Implant, Endosseous, Root-Form
DENTIUM CO., LTD. IMPLANTIUM
| Applicant | Dentium Co., Ltd., Dunwoody GA, US |
| Decision | Substantially Equivalent, Jul 29, 2004 |
| Received | May 24, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K041368
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2007 | Biomedicare, Inc. Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308, FX4310, FX4312, FX4314, FX4808, FX4810, FX4812, FX4814, FX4814W Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.