510(k) K051614 ยท DZE Implant, Endosseous, Root-Form
PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS
| Applicant | Lifecore Biomedical, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Sep 9, 2005 |
| Received | Jun 17, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K051614
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2018 | Keystone Dental Inc Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K
Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit res Terminated |
DZE | None listed |
| Jun 20, 2017 | Keystone Dental Inc Multi-Unit Abutment Angled, 17, 4mm Cuff 4.1/4.5mm TiLobe Implants, Catalog Number 45324K
pRODUCT Usage:
Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple- Terminated |
NHA | None listed |
| Apr 13, 2017 | Keystone Dental Inc Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm.
Catalog Number(s): 15636K Terminated |
DZE | None listed |
| Oct 21, 2016 | Keystone Dental Inc Keystone Dental PrimaConnex Straight Implant TC, RD Internal Connection 4.0 x 11.5mm.
Product code:15613K
Implants are intended for use in partially or fully edentulous mandibles and maxillae, in supp Terminated |
DZE | None listed |
| Mar 20, 2013 | Keystone Dental Inc PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm
Catalog Number: l5613K.
Implants in support for fixed bridgework. Terminated |
NDP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.