510(k) K081396 ยท NHA Abutment, Implant, Dental, Endosseous
SWISSPLANT DENTAL IMPLANT SYSTEM
| Applicant | Implant Direct, LLC, Calabasas CA, US |
| Decision | Substantially Equivalent, Jan 14, 2009 |
| Received | May 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081396
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2020 | Implant Direct Sybron Manufacturing LLC SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 Terminated |
NHA | None listed |
| Jan 19, 2018 | Implant Direct Sybron Manufacturing, LLC SwishPlus Implant
Intended for use in support for fixed bridgework. Terminated |
NHA | None listed |
| Dec 8, 2015 | Implant Direct Sybron Manufacturing, LLC DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patie Terminated |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.