510(k) K243278 ยท NHA Abutment, Implant, Dental, Endosseous
Custom Abutments
| Applicant | Institut Straumann AG, Basal, CH |
| Decision | Substantially Equivalent, Feb 21, 2025 |
| Received | Oct 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243278
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2026 | Straumann USA LLC Custom Abutment AS Ti, for Straumann RC, incl. TAN screw;
Catalog Number/Art.: 010.5438; Open, Classified |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.