510(k) K071370 ยท DZE Implant, Endosseous, Root-Form
NOBELACTIVE INTERNAL CONNECTION IMPLANT
| Applicant | Nobel Biocare AB, Yorba Linda, CA, US |
| Decision | Substantially Equivalent, Aug 3, 2007 |
| Received | May 16, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071370
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2019 | Nobel Biocare Usa Llc Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used Terminated |
NHA | None listed |
| Aug 9, 2019 | Nobel Biocare Usa Llc Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be us Terminated |
NHA | None listed |
| Jul 19, 2019 | Nobel Biocare Usa Llc NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619 Terminated |
NHA | None listed |
| May 28, 2019 | Nobel Biocare Usa Llc Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.