510(k) K072589 ยท DZE Implant, Endosseous, Root-Form
TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16
| Applicant | Zimmer Dental, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Oct 4, 2007 |
| Received | Sep 14, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072589
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Zimmer Dental Inc Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10. Terminated |
DZE | None listed |
| Oct 30, 2014 | Zimmer Dental Inc Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform
Part No. TSV4B10
Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform
Part No. TSV4B11
The Tapered Screw-Vent Implants Terminated |
DZE | None listed |
| Jan 28, 2014 | Zimmer Dental Inc Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008.
Class II, 510(k) K13227. Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.