510(k) K012911 ยท DZE Implant, Endosseous, Root-Form
3I LOCATER ABUTMENT SYSTEM
| Applicant | Implant Innovations, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Sep 28, 2001 |
| Received | Aug 30, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012911
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2016 | Biomet 3i, LLC Locator Extended Range Males 4pk
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Locator Extra Light Angled Replacement Males 4pk
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Locator Extra Light Retention Males 4pk
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Locator Light Retention Replacement Males 4pk
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Locator Replacement Housing
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Locator Replacement Housing Kit
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Locator Replacement Males 4pk
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Locator Abutment
Dental implants Terminated |
DZE | None listed |
| Aug 12, 2016 | Biomet 3i, LLC Certain Locator Abutment
Dental implants Terminated |
DZE | None listed |
| Feb 22, 2010 | Biomet 3i, LLC LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2mm(H), STERILE Made in USA, Sterile.
BIOMET 3i 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA.
For Terminated |
DZE | None listed |
| Feb 7, 2008 | Biomet 3i, Inc. BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, BioMet 3i, Palm Beach, FL. Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.