Not currently registered with FDA under this name
Biomet 3i, LLC
Palm Beach Gardens, FL, United States. Named as applicant on 32 dental 510(k) clearances between 2007 and 2025. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 322007–2025
- Markets registered in
- 10367 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 10 markets
Where regulators' registries name Biomet 3i, LLC as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Biomet 3i, LLC | 32 clearances | 2007–2025 | Below |
| Saudi Arabia | SFDA | Manufacturer | Biomet 3I LLC | 126 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | BIOMET 3I, LLC | 49 | 1999–2013 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Biomet 3iBIOMET 3i | 45 | 1999–2012 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | BIOMET 3iBIOMET 3I, LLC · BIOMET 3I | 42 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | BIOMET 3IBIOMET 3I, LLC | 40 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BIOMET 3IBIOMET 3I, LLC · BIOMET 3i, LLC · +1 | 30 | 2000–2022 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BIOMET 3I, LLC.BIOMET 3I LLC · BIOMET 3I · +1 | 20 | 2002–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | Biomet 3i LLCBIOMET 3i, LLC · Biomet 3i | 12 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BIOMET 3I | 3 | 2010–2017 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Biomet 3i, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Jun 2025 | K251660 | T3 Pro Implants ZimVie Packaging System | DZE Root-Form Endosseous Implant |
| 23 Oct 2024 | K241753 | Immediate Molar Implants | DZE Root-Form Endosseous Implant |
| 15 Jul 2024 | K241032 | BellaTek Bars | NHA Endosseous Dental Implant Abutment |
| 14 Sep 2022 | K220978 | TSX Implants | DZE Root-Form Endosseous Implant |
| 28 Mar 2022 | K213672 | T3 Pro Implants | DZE Root-Form Endosseous Implant |
| 21 Dec 2021 | K212730 | BellaTek Encode Emergence Healing Abutments | NHA Endosseous Dental Implant Abutment |
| 9 Dec 2019 | K192522 | TSV BellaTek Express and BellaTek Flex Abutments | NHA Endosseous Dental Implant Abutment |
| 2 Jul 2019 | K183138 | Certain BellaTek Express and BellaTek Flex Abutments | NHA Endosseous Dental Implant Abutment |
| 13 Dec 2017 | K173374 | TSV BellaTek Encode Healing Abutments | NHA Endosseous Dental Implant Abutment |
| 21 Sep 2017 | K170013 | Eztetic BellaTek Encode Healing Abutments | NHA Endosseous Dental Implant Abutment |
| 20 Nov 2015 | K150571 | 3i T3 Short Implants | DZE Root-Form Endosseous Implant |
| 8 Jan 2014 | K133049 | 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 30 Jul 2013 | K130949 | CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 21 Jun 2013 | K130310 | CERTAIN BELLATEK PROVISIONAL ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 30 Jan 2013 | K122300 | T3 DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 11 Sep 2012 | K120776 | ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION | NHA Endosseous Dental Implant Abutment |
| 13 Jan 2012 | K112730 | ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION | NHA Endosseous Dental Implant Abutment |
| 18 Nov 2011 | K111216 | OSSEOTITE 2 DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 1 Sep 2011 | K110565 | ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE | NHA Endosseous Dental Implant Abutment |
| 13 May 2011 | K110449 | ENDOBON XENOGRAFT GRANULES | LYC Synthetic Bone Grafting Material |
| 1 Apr 2011 | K100724 | OSSEOTITE II MODEL XIFOSSXXX | DZE Root-Form Endosseous Implant |
| 11 Mar 2011 | K101608 | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 11 Mar 2011 | K101607 | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 3 Dec 2010 | K102209 | ENCODE PATIENT SPECIFIC ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 8 Nov 2010 | K101582 | CAM STRUCTSURE BARS | NHA Endosseous Dental Implant Abutment |
| 30 Nov 2009 | K092341 | LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION | NHA Endosseous Dental Implant Abutment |
| 21 Jul 2008 | K080864 | CAM STRUCTSURE PRECISION MILLED BARS | NHA Endosseous Dental Implant Abutment |
| 7 Mar 2008 | K073345 | CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 31 Jan 2008 | K072363 | NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX | DZE Root-Form Endosseous Implant |
| 20 Dec 2007 | K072642 | BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS | NHA Endosseous Dental Implant Abutment |
| 30 Aug 2007 | K071551 | QUICKBRIDGE TM CYLINDER AND CAP | NHA Endosseous Dental Implant Abutment |
| 14 May 2007 | K070147 | INTERGRO ORAL | NUN Human Source Bone Grafting Material |
Some of these clearances are listed with FDA today by another company: ZimVie US Corp LLC (25), ARCH Medical Solutions - Escondido LLC (2), Smart Denture Conversions, LLC (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.