510(k) K070905 ยท DZE Implant, Endosseous, Root-Form
ENDOSSEOUS DENTAL IMPLANT SYSTEM
| Applicant | Southern Implants, Inc., Fairfax VA, US |
| Decision | Substantially Equivalent, May 24, 2007 |
| Received | Apr 2, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070905
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2013 | Southern Implants, Inc Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5.
The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable Terminated |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.