510(k) K053152 ยท DZE Implant, Endosseous, Root-Form
BIOHORIZONS SINGLE-STAGE IMPLANT
| Applicant | BioHorizons Implant Systems, Inc., Birmingham AL, US |
| Decision | Substantially Equivalent, Dec 2, 2005 |
| Received | Nov 10, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053152
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2010 | BioHorizons Implant Systems Inc Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiated, expires 2014-44, CE 0473, BIOHORIZONS, BIRMINGHAM, AL 35244.
Endosseous dental implant healing abutment. Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.