510(k) K061319 ยท DZE Implant, Endosseous, Root-Form
SPECTRA SYSTEM
| Applicant | Implant Direct, LLC, Calabasas CA, US |
| Decision | Substantially Equivalent, Sep 29, 2006 |
| Received | May 11, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061319
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2018 | Implant Direct Sybron Manufacturing, LLC ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. Terminated |
DZE | None listed |
| May 18, 2018 | Implant Direct Sybron Manufacturing, LLC REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60 Terminated |
DZE | None listed |
| May 2, 2017 | Implant Direct Sybron Manufacturing, LLC Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD Terminated |
DZE | None listed |
| Aug 2, 2016 | Implant Direct Sybron Manufacturing, LLC RePlant Angled Abutment
Part Number 6050-52-60 Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.