510(k) K100724 ยท DZE Implant, Endosseous, Root-Form
OSSEOTITE II MODEL XIFOSSXXX
| Applicant | Biomet 3i, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Apr 1, 2011 |
| Received | Mar 15, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100724
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2015 | Biomet 3i, LLC OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm.
Dental Implants. Terminated |
DZE | None listed |
| Sep 16, 2013 | Biomet 3i, LLC Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant
Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth r Terminated |
DZE | None listed |
| Nov 16, 2012 | Biomet 3i, LLC Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile.
Product provides a means for prosthetic attachment in single tooth restoration Terminated |
DZE | None listed |
| Nov 16, 2012 | Biomet 3i, LLC Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile.
Product provides a means for prosthetic attachment in single tooth restorations and in partia Terminated |
DZE | None listed |
| Nov 8, 2011 | Biomet 3i, LLC ***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiation***Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n 08940 Cornella Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.