510(k) K173418 ยท DZE Implant, Endosseous, Root-Form
NobelParallel Conical Connection
| Applicant | Nobel Biocare AB, Goteborg, SE |
| Decision | Substantially Equivalent, Feb 21, 2019 |
| Received | Nov 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173418
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2020 | Nobel Biocare Usa Llc NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI
(01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw b Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.