510(k) K130572 ยท DZE Implant, Endosseous, Root-Form
INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM
| Applicant | Implant Direct Sybron Manufacturing, LLC, Calabasas CA, US |
| Decision | Substantially Equivalent, Dec 24, 2013 |
| Received | Mar 4, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130572
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 26, 2018 | Implant Direct Sybron Manufacturing, LLC Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R
Dental Implant Terminated |
DZE | None listed |
| Mar 14, 2018 | Implant Direct Sybron Manufacturing, LLC ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL.
Product Usage: Usage:
Den Terminated |
DZE | None listed |
| Jan 23, 2018 | Implant Direct Sybron Manufacturing, LLC Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform Terminated |
NHA | None listed |
| Mar 3, 2017 | Implant Direct Sybron Manufacturing, LLC ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.