510(k) K063286 ยท DZE Implant, Endosseous, Root-Form
OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE
| Applicant | Implant Innovations, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Apr 24, 2007 |
| Received | Oct 31, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2017 | Biomet 3i, LLC BIOMET 3i LTX DENTAL IMPLANTS
Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile" Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Cover Screw
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Cover Screw, Headless
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Implant Cover Screw
Dental implants Terminated |
DZE | None listed |
| Sep 18, 2007 | Biomet 3i Product is labeled as LTX XP Miniplant, Dental Implant, Sterile. Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.