510(k) K934126 ยท DZE Implant, Endosseous, Root-Form
ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS
| Applicant | Implant Innovations, Inc., West Palm Baeach FL, US |
| Decision | Substantially Equivalent, Apr 25, 1994 |
| Received | Aug 25, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934126
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2016 | Biomet 3i, LLC Provide Protection Cap
Dental implants Terminated |
DZE | None listed |
| Jan 6, 2016 | Biomet 3i, LLC BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655
BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the Terminated |
DZE | None listed |
| Jan 6, 2016 | Biomet 3i, LLC BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK614 Terminated |
DZE | None listed |
| Jul 13, 2011 | Biomet 3i, LLC "***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment*** STERILE.***Rx Only.*** Made in USA*** Implant Innovations, Inc. Global Headquarters 4555 Riverside Drive, Terminated |
NSQ | None listed |
| Jun 14, 2007 | Biomet 3i EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant. Terminated |
DZE | None listed |
| May 16, 2007 | Biomet 3i Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36. Terminated |
DZE | None listed |
| Oct 21, 2004 | Implant Innovations, Inc. EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant. Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.