510(k) K974150 ยท NHA Abutment, Implant, Dental, Endosseous
PROCERA PREPARABLE ABUTMENT SYSTEM
| Applicant | Nobel Biocare Uas, Inc., Westmont IL, US |
| Decision | Substantially Equivalent, Jan 23, 1998 |
| Received | Nov 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974150
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2019 | Nobel Biocare Usa Llc Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to b Terminated |
NHA | None listed |
| Aug 9, 2019 | Nobel Biocare Usa Llc Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be Terminated |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.