510(k) K073268 ยท DZE Implant, Endosseous, Root-Form
BIOHORIZONS INTERNAL IMPLANT SYSTEM
| Applicant | BioHorizons Implant Systems, Inc., Birmingham AL, US |
| Decision | Substantially Equivalent, Feb 8, 2008 |
| Received | Nov 20, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073268
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2015 | BioHorizons Implant Systems Inc RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R),
Dental Implant Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.