510(k) K041938 ยท DZE Implant, Endosseous, Root-Form
MAXIMUS OS (OVERDENTURE SYSTEM)
| Applicant | BioHorizons Implant Systems, Inc., Birmingham AL, US |
| Decision | Substantially Equivalent, Jul 22, 2004 |
| Received | Jul 19, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041938
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2007 | BioHorizons Implant Systems Inc Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243 Terminated |
DZE | None listed |
| Dec 6, 2006 | BioHorizons Implant Systems Inc BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.