510(k) K161435 ยท NHA Abutment, Implant, Dental, Endosseous
Temporary Snap Abutment
| Applicant | Nobel Biocare AB, Goteborg, SE |
| Decision | Substantially Equivalent, Nov 22, 2016 |
| Received | May 24, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161435
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2019 | Nobel Biocare Usa Llc Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are inte Terminated |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.