510(k) K071161 ยท DZE Implant, Endosseous, Root-Form
ENDOSSEOUS DENTAL IMPLANT SYSTEM
| Applicant | Southern Implants, Inc., Fairfax VA, US |
| Decision | Substantially Equivalent, Nov 16, 2007 |
| Received | Apr 26, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071161
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2017 | Keystone Dental Inc Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7
Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and Terminated |
DZE | None listed |
| Mar 12, 2015 | Southern Implants, Inc MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant.
Product Usage:
The MAX Implant is intended to be implanted in the upper and Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.