510(k) K063341 ยท DZE Implant, Endosseous, Root-Form
3I OSSEOTITE CERTAIN DENTAL IMPLANTS
| Applicant | Implant Innovations, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Apr 30, 2007 |
| Received | Nov 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063341
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2016 | Biomet 3i, LLC Certain Implant Cover Screw
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Implant Straight Cover Screw
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Micromini Flat Implant Cover Screw
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Cover Screw
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Flat Implant Cover Screw
Dental implants Terminated |
DZE | None listed |
| Aug 8, 2016 | Biomet 3i, LLC 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only. Terminated |
DZE | None listed |
| Sep 16, 2013 | Biomet 3i, LLC Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant
Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restoration Terminated |
DZE | None listed |
| Oct 23, 2012 | Biomet 3i, LLC Osseotite Tapered Certain Implant 5 X 10mm Model INT510
Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single Terminated |
DZE | None listed |
| Aug 8, 2012 | Biomet 3i, LLC ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Terminated |
NHA | None listed |
| Jun 20, 2012 | Biomet 3i, LLC Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. .
Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.