510(k) K011028 ยท DZE Implant, Endosseous, Root-Form
SCREW-VENT DENTAL IMPLANT SYSTEM
| Applicant | Sulzer Dental, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, May 21, 2001 |
| Received | Apr 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011028
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2017 | Zimmer Dental Inc ABUT GOLD FRICTION-FIT, REF HLA3G;
ABUT GOLD FRICTION-FIT, REF HLA4G;
COPING GOLD ENG 5.7 MM, REF HLA5G;
COPING GOLD NON-ENG. 3.5, REF NEA3G;
COPING GOLD NON-ENG. 4.5, REF NEA4G Terminated |
DZE | None listed |
| Aug 2, 2014 | Zimmer, Inc. Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component. Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.