Biomet 3i, LLC
FDA Regulatory Profile
Biomet 3i, LLC appears in FDA public data with 222 recalls, 32 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0075-2021, Class II) was initiated on August 31, 2020. Its most recent 510(k) clearance was granted on June 27, 2025.
Summary
- Total Recalls
- 222
- 510(k) Clearances
- 32
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0075-2021 | Class II | CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4 | August 31, 2020 |
| Z-0076-2021 | Class II | CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5 | August 31, 2020 |
| Z-0079-2021 | Class II | CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6 | August 31, 2020 |
| Z-0073-2021 | Class II | BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ | August 31, 2020 |
| Z-0074-2021 | Class II | BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4 | August 31, 2020 |
| Z-0077-2021 | Class II | CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4 | August 31, 2020 |
| Z-0078-2021 | Class II | CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5 | August 31, 2020 |
| Z-1368-2020 | Class II | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number: IEHA346 | January 10, 2020 |
| Z-1388-2020 | Class II | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574 | January 10, 2020 |
| Z-1370-2020 | Class II | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA354 | January 10, 2020 |
| Z-1387-2020 | Class II | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566 | January 10, 2020 |
| Z-1367-2020 | Class II | CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344 | January 10, 2020 |
| Z-1380-2020 | Class II | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466 | January 10, 2020 |
| Z-1385-2020 | Class II | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA | January 10, 2020 |
| Z-1372-2020 | Class II | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443 | January 10, 2020 |
| Z-1382-2020 | Class II | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553 | January 10, 2020 |
| Z-1377-2020 | Class II | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456 | January 10, 2020 |
| Z-1381-2020 | Class II | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474 | January 10, 2020 |
| Z-1384-2020 | Class II | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563 | January 10, 2020 |
| Z-1376-2020 | Class II | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454 | January 10, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251660 | T3 Pro Implants ZimVie Packaging System | June 27, 2025 |
| K241753 | Immediate Molar Implants | October 23, 2024 |
| K241032 | BellaTek Bars | July 15, 2024 |
| K220978 | TSX Implants | September 14, 2022 |
| K213672 | T3 Pro Implants | March 28, 2022 |
| K212730 | BellaTek Encode Emergence Healing Abutments | December 21, 2021 |
| K192522 | TSV BellaTek Express and BellaTek Flex Abutments | December 9, 2019 |
| K183138 | Certain BellaTek Express and BellaTek Flex Abutments | July 2, 2019 |
| K173374 | TSV BellaTek Encode Healing Abutments | December 13, 2017 |
| K170013 | Eztetic BellaTek Encode Healing Abutments | September 21, 2017 |
| K150571 | 3i T3 Short Implants | November 20, 2015 |
| K133049 | 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS | January 8, 2014 |
| K130949 | CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS | July 30, 2013 |
| K130310 | CERTAIN BELLATEK PROVISIONAL ABUTMENTS | June 21, 2013 |
| K122300 | T3 DENTAL IMPLANT | January 30, 2013 |
| K120776 | ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION | September 11, 2012 |
| K112730 | ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION | January 13, 2012 |
| K111216 | OSSEOTITE 2 DENTAL IMPLANTS | November 18, 2011 |
| K110565 | ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE | September 1, 2011 |
| K110449 | ENDOBON XENOGRAFT GRANULES | May 13, 2011 |