510(k) K111889 ยท DZE Implant, Endosseous, Root-Form
ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT
| Applicant | Zimmer Dental, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Dec 6, 2011 |
| Received | Jul 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111889
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2018 | Zimmer Dental Inc Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10.
Zimmer Dental Impl Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.