ZimVie US Corp LLC
Palm Beach Gardens, FL, US
ZimVie US Corp LLC appears in FDA device records in Palm Beach Gardens, FL. FDA records list 123 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 294 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to ZimVie US Corp LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Biomet 3i, LLC510(k), enforcement report, recall
- Implant Innovations, Inc.510(k), recall
- Zimmer Dental, Inc.510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 123FDA records hold 123 510(k) clearances for ZimVie US Corp LLC between 1994 and 2025. The busiest year on record is 2007, with 13. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 3 |
| 1995 | 5 |
| 1996 | 7 |
| 1997 | 4 |
| 1998 | 2 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 3 |
| 2002 | 3 |
| 2003 | 4 |
| 2004 | 3 |
| 2005 | 4 |
| 2006 | 11 |
| 2007 | 13 |
| 2008 | 6 |
| 2009 | 5 |
| 2010 | 4 |
| 2011 | 10 |
| 2012 | 6 |
| 2013 | 4 |
| 2014 | 7 |
| 2015 | 4 |
| 2017 | 3 |
| 2019 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2024 | 2 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251660 | T3 Pro Implants– ZimVie Packaging System | DZE | Substantially Equivalent | |
| K241753 | Immediate Molar Implants | DZE | Substantially Equivalent | |
| K241032 | BellaTek Bars | NHA | Substantially Equivalent | |
| K220978 | TSX Implants | DZE | Substantially Equivalent | |
| K213672 | T3 Pro Implants | DZE | Substantially Equivalent | |
| K212730 | BellaTek Encode Emergence Healing Abutments | NHA | Substantially Equivalent | |
| K192522 | TSV BellaTek Express and BellaTek Flex Abutments | NHA | Substantially Equivalent | |
| K183138 | Certain BellaTek Express and BellaTek Flex Abutments | NHA | Substantially Equivalent | |
| K173374 | TSV BellaTek Encode Healing Abutments | NHA | Substantially Equivalent | |
| K170013 | Eztetic BellaTek Encode Healing Abutments | NHA | Substantially Equivalent | |
| K160398 | MRI Compatibility for Existing Zimmer Dental Implant Systems | DZE | Substantially Equivalent | |
| K150571 | 3i T3 Short Implants | DZE | Substantially Equivalent | |
| K143505 | Zimmer Patient-Specific Abutment, Internal Hex, Titanium | NHA | Substantially Equivalent | |
| K143528 | Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System | NHA | Substantially Equivalent | |
| K142572 | Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System | NHA | Substantially Equivalent | |
| K142082 | ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT | DZE | Substantially Equivalent | |
| K141544 | ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM | NHA | Substantially Equivalent | |
| K141120 | ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM | NHA | Substantially Equivalent | |
| K133551 | ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM | NHA | Substantially Equivalent | |
| K134045 | ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM | NHA | Substantially Equivalent | |
| K133339 | ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED | DZE | Substantially Equivalent | |
| K133049 | 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS | DZE | Substantially Equivalent | |
| K132258 | ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K130949 | CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS | DZE | Substantially Equivalent | |
| K130310 | CERTAIN BELLATEK PROVISIONAL ABUTMENTS | NHA | Substantially Equivalent | |
| K122300 | T3 DENTAL IMPLANT | DZE | Substantially Equivalent | |
| K120873 | ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM | NHA | Substantially Equivalent | |
| K121709 | ZFX DENTAL CAD SYSTEM | NHA | Substantially Equivalent | |
| K120776 | ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION | NHA | Substantially Equivalent | |
| K113753 | ZIMMER DENTAL TAPERED SCREW-VENT X | DZE | Substantially Equivalent | |
| K113092 | ZIMMER CONTOUR PROVISIONAL COPING | NHA | Substantially Equivalent | |
| K112730 | ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION | NHA | Substantially Equivalent | |
| K112160 | TAPERED SCREW-VENT X IMPLANT | DZE | Substantially Equivalent | |
| K111853 | ANGLED TAPERED ABUTMENT | NHA | Substantially Equivalent | |
| K111889 | ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT | DZE | Substantially Equivalent | |
| K111216 | OSSEOTITE 2 DENTAL IMPLANTS | DZE | Substantially Equivalent | |
| K110565 | ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE | NHA | Substantially Equivalent | |
| K111852 | ANODIZED HEALING COLLAR | NHA | Substantially Equivalent | |
| K110449 | ENDOBON XENOGRAFT GRANULES | LYC | Substantially Equivalent | |
| K100724 | OSSEOTITE II MODEL XIFOSSXXX | DZE | Substantially Equivalent | |
| K101608 | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS | NHA | Substantially Equivalent | |
| K101607 | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS | NHA | Substantially Equivalent | |
| K102209 | ENCODE PATIENT SPECIFIC ABUTMENT | NHA | Substantially Equivalent | |
| K101582 | CAM STRUCTSURE BARS | NHA | Substantially Equivalent | |
| K101880 | TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT | DZE | Substantially Equivalent | |
| K101977 | TAPERED SCREW-VENT T IMPLANT | DZE | Substantially Equivalent | |
| K093164 | 3.25 SPLINE TWIST IMPLANT, HA COATED | DZE | Substantially Equivalent | |
| K092341 | LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION | NHA | Substantially Equivalent | |
| K092377 | PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S | NHA | Substantially Equivalent | |
| K092403 | TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620 | NHA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1038806 | 1038806 | ZimVie US Corp LLC | 4555 Riverside Drive, Palm Beach Gardens, FL 33410 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- EGGAttachment, Precision, All
- NUNBone Grafting Material, Human Source
- LYCBone Grafting Material, Synthetic
- EJLBur, Dental
- JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- DZEImplant, Endosseous, Root-Form
- JEYPlate, Bone
- EBIResin, Denture, Relining, Repairing, Rebasing
- DZLScrew, Fixation, Intraosseous
- HWTTemplate
- FSMTray, Surgical, Instrument
Recall records
Showing 25 of 294| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0079-2021 | CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6 | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient | Class II | Terminated | |
| Z-0078-2021 | CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5 | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient | Class II | Terminated | |
| Z-0077-2021 | CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4 | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient | Class II | Terminated | |
| Z-0076-2021 | CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5 | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient | Class II | Terminated | |
| Z-0075-2021 | CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4 | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient | Class II | Terminated | |
| Z-0074-2021 | BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4 | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient | Class II | Terminated | |
| Z-0073-2021 | BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ | Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient | Class II | Terminated | |
| Z-1388-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1387-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1386-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1385-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1384-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1383-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1382-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1381-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1380-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1379-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA464 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1378-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1377-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1376-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1375-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1374-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1373-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1372-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated | |
| Z-1371-2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356 | Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain