Company · US
Biomet 3i, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2025. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (0 in 12 months)
245recalls (0 in 12 months)
199recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 193 |
| DZE | Implant, Endosseous, Root-Form | 63 |
| LRO | General Surgery Tray | 5 |
| NDP | Accessories, Implant, Dental, Endosseous | 5 |
| LYC | Bone Grafting Material, Synthetic | 2 |
| O-F | 2 | |
| DZA | Drill, Dental, Intraoral | 1 |
| DZL | Screw, Fixation, Intraosseous | 1 |
| EJB | Handle, Instrument, Dental | 1 |
| NDA | Helmet, Cranial, For Protective Use | 1 |
| NSP | Restoration, Porcelain | 1 |
| NSQ | Restoration, Base Metal | 1 |
| NUN | Bone Grafting Material, Human Source | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 27, 2025 | K251660 | T3 Pro Implants– ZimVie Packaging System Biomet 3i, LLC | DZE |
| Oct 23, 2024 | K241753 | Immediate Molar Implants Biomet 3i, LLC | DZE |
| Jul 15, 2024 | K241032 | BellaTek Bars Biomet 3i, LLC | NHA |
| Sep 14, 2022 | K220978 | TSX Implants Biomet 3i, LLC | DZE |
| Mar 28, 2022 | K213672 | T3 Pro Implants Biomet 3i, LLC | DZE |
| Dec 21, 2021 | K212730 | BellaTek Encode Emergence Healing Abutments Biomet 3i, LLC | NHA |
| Dec 9, 2019 | K192522 | TSV BellaTek Express and BellaTek Flex Abutments Biomet 3i, LLC | NHA |
| Jul 2, 2019 | K183138 | Certain BellaTek Express and BellaTek Flex Abutments Biomet 3i | NHA |
| Dec 13, 2017 | K173374 | TSV BellaTek Encode Healing Abutments Biomet 3i | NHA |
| Sep 21, 2017 | K170013 | Eztetic BellaTek Encode Healing Abutments Biomet 3i | NHA |
| Nov 20, 2015 | K150571 | 3i T3 Short Implants Biomet 3i | DZE |
| Jan 8, 2014 | K133049 | 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS Biomet 3i | DZE |
| Jul 30, 2013 | K130949 | CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS Biomet 3i | DZE |
| Jun 21, 2013 | K130310 | CERTAIN BELLATEK PROVISIONAL ABUTMENTS Biomet 3i | NHA |
| Jan 30, 2013 | K122300 | T3 DENTAL IMPLANT Biomet 3i | DZE |
| Sep 11, 2012 | K120776 | ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION Biomet 3i | NHA |
| Jan 13, 2012 | K112730 | ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION Biomet 3i | NHA |
| Nov 18, 2011 | K111216 | OSSEOTITE 2 DENTAL IMPLANTS Biomet 3i, Inc. | DZE |
| Sep 1, 2011 | K110565 | ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE Biomet 3i, Inc. | NHA |
| May 13, 2011 | K110449 | ENDOBON XENOGRAFT GRANULES Biomet 3i | LYC |
| Apr 1, 2011 | K100724 | OSSEOTITE II MODEL XIFOSSXXX Biomet 3i, Inc. | DZE |
| Mar 11, 2011 | K101608 | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS Biomet 3i, Inc. | NHA |
| Mar 11, 2011 | K101607 | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS Biomet 3i, Inc. | NHA |
| Dec 3, 2010 | K102209 | ENCODE PATIENT SPECIFIC ABUTMENT Biomet 3i, Inc. | NHA |
| Nov 8, 2010 | K101582 | CAM STRUCTSURE BARS Biomet 3i, Inc. | NHA |
| Nov 30, 2009 | K092341 | LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION Biomet 3i, Inc. | NHA |
| Jul 21, 2008 | K080864 | CAM STRUCTSURE PRECISION MILLED BARS Biomet 3i, Inc. | NHA |
| Mar 7, 2008 | K073345 | CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT Biomet 3i, Inc. | NHA |
| Jan 31, 2008 | K072363 | NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX Biomet 3i, Inc. | DZE |
| Dec 20, 2007 | K072642 | BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS Biomet 3i, Inc. | NHA |
| Aug 30, 2007 | K071551 | QUICKBRIDGE TM CYLINDER AND CAP Biomet 3i, Inc. | NHA |
| May 14, 2007 | K070147 | INTERGRO ORAL Biomet 3i | NUN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2020 | Biomet 3i, LLC CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM
Reference Number: IEDAT6 Terminated |
NHA | K052648 |
| Aug 31, 2020 | Biomet 3i, LLC CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM
Reference Number: IEDAT5 Terminated |
NHA | K052648 |
| Aug 31, 2020 | Biomet 3i, LLC CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM
Reference Number: IEDAT4 Terminated |
NHA | K052648 |
| Aug 31, 2020 | Biomet 3i, LLC CERTAIN BELLATEK TIN ABUTMENT 5.0MM
Reference Number: IEDAN5 Terminated |
NHA | K052648 |
| Aug 31, 2020 | Biomet 3i, LLC CERTAIN BELLATEK TIN ABUTMENT 4.1MM
Reference Number: IEDAN4 Terminated |
NHA | K052648 |
| Aug 31, 2020 | Biomet 3i, LLC BELLATEK TITANIUM ABUTMENT 4.1MM
Reference Number: EDAT4 Terminated |
NHA | K052648 |
| Aug 31, 2020 | Biomet 3i, LLC BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model
Reference Numbers: 3DPMSER, 3DPMSERQ Terminated |
NHA | K052648 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number:
IEHA574 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H)
Reference Number: IEHA566 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H)
Reference Number: IEHA564 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H)
Reference Number: IEHA564 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H)
Reference Number: IEHA563 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H)
Reference Number: IEHA554 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H)
Reference Number: IEHA553 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H)
Reference Number: IEHA474 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H)
Reference Number: IEHA466 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H)
Reference Number: IEHA464 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H)
Reference Number: IEHA463 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H)
Reference Number: IEHA456 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H)
Reference Number: IEHA454 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H)
Reference Number: IEHA453 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H)
Reference Number: IEHA446 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H)
Reference Number: IEHA444 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H)
Reference Number: IEHA443 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H)
Reference Number: IEHA356 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H)
Reference Number: IEHA354 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H)
Reference Number: IEHA353 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H)
Reference Number: IEHA346 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H)
Reference Number: IEHA344 Terminated |
NHA | K072642 |
| Jan 10, 2020 | Biomet 3i, LLC CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H)
Reference Number: IEHA343 Terminated |
NHA | K072642 |
| 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 | K052648 K102209 |
| 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 | K052648 K102209 |
| 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 | K052648 K102209 |
| 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 | K052648 K102209 |
| 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 | K052648 K102209 |
| Mar 8, 2017 | Biomet 3i, LLC BIOMET 3i LTX DENTAL IMPLANTS
Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile" Terminated |
DZE | K063286 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is inten Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental impla Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is inte Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use a Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental imp Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implan Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use a Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is in Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is in Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is in Terminated |
NHA | K092341 |
| Sep 14, 2016 | Biomet 3i, LLC BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H)
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is in Terminated |
NHA | K092341 |
Newest 50 of 245.