510(k) K071638 ยท DZE Implant, Endosseous, Root-Form
BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM
| Applicant | BioHorizons Implant Systems, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 10, 2007 |
| Received | Jun 15, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071638
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2025 | DDS Lab Temporary Titanium Abutments Open, Classified |
NHA | None listed |
| May 12, 2015 | BioHorizons Implant Systems Inc Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only,
Product Usage Usage:
Surgical instruments used in preparation for dental implant placement Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.