510(k) K121131 ยท DZE Implant, Endosseous, Root-Form
BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM
| Applicant | Straumann USA, Andover MA, US |
| Decision | Substantially Equivalent, Jun 6, 2012 |
| Received | Apr 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121131
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2014 | Straumann USA, LLC Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim
Article Number: 021.4308
Product Usage:
Dental implants are intended for surgical placement in maxillary and/or mandibular arches Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.