510(k) K052648 ยท NHA Abutment, Implant, Dental, Endosseous
MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS
| Applicant | Implant Innovations, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Oct 20, 2005 |
| Received | Sep 26, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052648
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2020 | Biomet 3i, LLC BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model
Reference Numbers: 3DPMSER, 3DPMSERQ Terminated |
NHA | None listed |
| Aug 31, 2020 | Biomet 3i, LLC BELLATEK TITANIUM ABUTMENT 4.1MM
Reference Number: EDAT4 Terminated |
NHA | None listed |
| Aug 31, 2020 | Biomet 3i, LLC CERTAIN BELLATEK TIN ABUTMENT 4.1MM
Reference Number: IEDAN4 Terminated |
NHA | None listed |
| Aug 31, 2020 | Biomet 3i, LLC CERTAIN BELLATEK TIN ABUTMENT 5.0MM
Reference Number: IEDAN5 Terminated |
NHA | None listed |
| Aug 31, 2020 | Biomet 3i, LLC CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM
Reference Number: IEDAT4 Terminated |
NHA | None listed |
| Aug 31, 2020 | Biomet 3i, LLC CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM
Reference Number: IEDAT5 Terminated |
NHA | None listed |
| Aug 31, 2020 | Biomet 3i, LLC CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM
Reference Number: IEDAT6 Terminated |
NHA | None listed |
| Feb 26, 2019 | Biomet 3i, LLC CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the max Terminated |
NHA | None listed |
| Feb 26, 2019 | Biomet 3i, LLC CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in th Terminated |
NHA | None listed |
| Feb 26, 2019 | Biomet 3i, LLC CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in th Terminated |
NHA | None listed |
| Feb 26, 2019 | Biomet 3i, LLC CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the max Terminated |
NHA | None listed |
| Feb 26, 2019 | Biomet 3i, LLC CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the Terminated |
NHA | None listed |
| Mar 17, 2014 | Biomet 3i, LLC Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Ab Terminated |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.