510(k) K140878 ยท DZE Implant, Endosseous, Root-Form
STRAUMANN BONE LEVEL TAPERED IMPLANT
| Applicant | Straumann USA, LLC, Andover MA, US |
| Decision | Substantially Equivalent, Aug 20, 2014 |
| Received | Apr 7, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140878
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2026 | Straumann USA LLC Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form Open, Classified |
DZE | None listed |
| Oct 23, 2014 | Straumann USA, LLC Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim
Article Number: 021 .5308
Dental implants are intended for surgical placement in maxillary and/or mandibular arches to pr Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.