510(k) K102209 ยท NHA Abutment, Implant, Dental, Endosseous
ENCODE PATIENT SPECIFIC ABUTMENT
| Applicant | Biomet 3i, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Dec 3, 2010 |
| Received | Aug 5, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102209
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.