Data / Medical devices / Canada / ZimVie Canada Inc.
ZimVie Canada Inc.: FDA-registered device maker in Mississauga Ontario, Canada, 101 510(k) clearances
ZimVie Canada Inc. is registered with the FDA (registration 1000244346) in Mississauga Ontario, Canada. It lists 7 device types. The FDA files 101 510(k) clearances under its listings, the newest dated October 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000244346
- Address
- 2345 Argentia Rd Suite 106, Mississauga Ontario, Canada, L5N 8K4
- Owner or operator
- ZimVie US Corp LLC (1038806)
- Roles
- Exporter to the US
- First device listed
- December 29, 1993
- Registered through
- 2026
- Brand names listed
- 3i T3 Ex Hex Parallel Walled Implant, 3i T3 Ex Hex Tapered Implant, 3i T3 Non-Platform Switched Parallel Walled Implant, 3i T3 Non-Platform Switched Tapered Implant, 3i T3 Parallel Walled Implant, 3i T3 Short External Hex Parallel Walled Implant, 3i T3 Short External Hex Parallel Walled Implant with DCD, 3i T3 Tapered Implant and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Exporter to the US | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Exporter to the US | accessdata.fda.gov |
| Attachment, Precision, All | EGG | 1 | Exporter to the US | accessdata.fda.gov |
| Bone Grafting Material, Human Source | NUN | 2 | Exporter to the US | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Exporter to the US | accessdata.fda.gov |
| Template | HWT | 1 | Exporter to the US | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 101.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 23, 2024 | K241753 | Immediate Molar Implants | DZE | Substantially Equivalent | Biomet 3i, LLC | accessdata.fda.gov |
| September 14, 2022 | K220978 | TSX Implants | DZE | Substantially Equivalent | Biomet 3i, LLC | accessdata.fda.gov |
| March 28, 2022 | K213672 | T3 Pro Implants | DZE | Substantially Equivalent | Biomet 3i, LLC | accessdata.fda.gov |
| December 21, 2021 | K212730 | BellaTek Encode Emergence Healing Abutments | NHA | Substantially Equivalent | Biomet 3i, LLC | accessdata.fda.gov |
| December 9, 2019 | K192522 | TSV BellaTek Express and BellaTek Flex Abutments | NHA | Substantially Equivalent | Biomet 3i, LLC | accessdata.fda.gov |
| July 2, 2019 | K183138 | Certain BellaTek Express and BellaTek Flex Abutments | NHA | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| December 13, 2017 | K173374 | TSV BellaTek Encode Healing Abutments | NHA | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| November 20, 2015 | K150571 | 3i T3 Short Implants | DZE | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| June 25, 2015 | K143505 | Zimmer Patient-Specific Abutment, Internal Hex, Titanium | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| May 1, 2015 | K143528 | Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| January 21, 2015 | K142572 | Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| October 28, 2014 | K142082 | ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| March 4, 2014 | K133339 | ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| January 8, 2014 | K133049 | 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS | DZE | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| November 19, 2013 | K132258 | ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| July 30, 2013 | K130949 | CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS | DZE | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| January 30, 2013 | K122300 | T3 DENTAL IMPLANT | DZE | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| November 8, 2012 | K120873 | ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| September 11, 2012 | K120776 | ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION | NHA | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| August 30, 2012 | K113753 | ZIMMER DENTAL TAPERED SCREW-VENT X | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| January 23, 2012 | K113092 | ZIMMER CONTOUR PROVISIONAL COPING | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| January 20, 2012 | K113645 | REGENEROSS ALLOGRAFT PLUS MINERLIZED | NUN | Substantially Equivalent | Biomet Interpore Cross | accessdata.fda.gov |
| January 13, 2012 | K112730 | ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION | NHA | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| December 14, 2011 | K112160 | TAPERED SCREW-VENT X IMPLANT | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| December 8, 2011 | K111853 | ANGLED TAPERED ABUTMENT | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| December 6, 2011 | K111889 | ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| November 18, 2011 | K111216 | OSSEOTITE 2 DENTAL IMPLANTS | DZE | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| September 1, 2011 | K110565 | ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| August 11, 2011 | K111852 | ANODIZED HEALING COLLAR | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| April 1, 2011 | K100724 | OSSEOTITE II MODEL XIFOSSXXX | DZE | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| March 11, 2011 | K101608 | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| March 11, 2011 | K101607 | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| December 3, 2010 | K102209 | ENCODE PATIENT SPECIFIC ABUTMENT | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| November 8, 2010 | K101582 | CAM STRUCTSURE BARS | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| October 1, 2010 | K101880 | TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| September 14, 2010 | K101977 | TAPERED SCREW-VENT T IMPLANT | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| December 15, 2009 | K093164 | 3.25 SPLINE TWIST IMPLANT, HA COATED | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| November 30, 2009 | K092341 | LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| November 3, 2009 | K092377 | PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| October 30, 2009 | K092403 | TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620 | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| April 7, 2009 | K090723 | HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5, | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| December 23, 2008 | K083474 | ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| December 19, 2008 | K082639 | ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| September 25, 2008 | K080164 | ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| July 21, 2008 | K080864 | CAM STRUCTSURE PRECISION MILLED BARS | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| December 20, 2007 | K072642 | BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| December 3, 2007 | K072878 | MODIFICATION TO: LOCATOR IMPLANT ANCHOR | NHA | Substantially Equivalent | Zest Anchors, Inc. | accessdata.fda.gov |
| October 4, 2007 | K072589 | TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16 | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| September 20, 2007 | K071439 | ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| August 30, 2007 | K071551 | QUICKBRIDGE TM CYLINDER AND CAP | NHA | Substantially Equivalent | Biomet 3i, Inc. | accessdata.fda.gov |
| May 30, 2007 | K071235 | ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| May 14, 2007 | K070147 | INTERGRO ORAL | NUN | Substantially Equivalent | Biomet 3i | accessdata.fda.gov |
| April 30, 2007 | K063341 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS | DZE | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| April 24, 2007 | K063286 | OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE | DZE | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| March 20, 2007 | K063403 | CONICAL ANGLED ABUTMENT | NHA | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| February 23, 2007 | K061629 | CERTAIN PREVAIL DENTAL IMPLANT | DZE | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| October 12, 2006 | K061847 | ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| September 8, 2006 | K061410 | SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| July 21, 2006 | K061969 | PREFORMANCE POSTS AND TEMPORARY CYLINDERS | NHA | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| May 17, 2006 | K060880 | ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C1 | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| February 27, 2006 | K060291 | PREFORMANCE TEMPORARY CYLINDER | NHA | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| February 1, 2006 | K053170 | PREFORMANCE POSTS | NHA | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| January 23, 2006 | K052997 | ZIMMER DENTAL ONE-PIECE IMPLANT | DZE | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| October 20, 2005 | K052648 | MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS | NHA | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| October 13, 2005 | K052600 | ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED) | NHA | Substantially Equivalent | Zimmer Dental, Inc. | accessdata.fda.gov |
| September 15, 2005 | K051461 | 3I OSSEOTITE DENTAL IMPLANTS | DZE | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| November 13, 2002 | K014050 | HEX-LOCK TEMPORARY ABUTMENT | DZE | Substantially Equivalent | Sulzer Dental, Inc. | accessdata.fda.gov |
| September 19, 2002 | K022113 | 3I DENTAL IMPLANT ACCESSORIES | DZE | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| January 18, 2002 | K013494 | 3.75MM AND 5.0MM SPLINE TWIST IMPLANT | DZE | Substantially Equivalent | Sulzer Dental, Inc. | accessdata.fda.gov |
| November 19, 2001 | K013227 | SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT | DZE | Substantially Equivalent | Sulzer Dental, Inc. | accessdata.fda.gov |
| September 28, 2001 | K012911 | 3I LOCATER ABUTMENT SYSTEM | DZE | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| June 25, 2001 | K011245 | ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM | DZE | Substantially Equivalent | Sulzer Dental, Inc. | accessdata.fda.gov |
| May 21, 2001 | K011028 | SCREW-VENT DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Sulzer Dental, Inc. | accessdata.fda.gov |
| May 15, 2001 | K011038 | TAPER-LOCK DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Sulzer Dental, Inc. | accessdata.fda.gov |
| January 19, 2001 | K010073 | SPLINE DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Sulzer Calcitek, Inc. | accessdata.fda.gov |
| December 8, 2000 | K002614 | ADVENT IMPLANT SYSTEM | DZE | Substantially Equivalent | Core-Vent Corp. | accessdata.fda.gov |
| October 30, 2000 | K002188 | SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D, | DZE | Substantially Equivalent | Core-Vent Corp. | accessdata.fda.gov |
| June 21, 2000 | K001786 | TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG | DZE | Substantially Equivalent | Sulzer Calcitek, Inc. | accessdata.fda.gov |
| September 22, 1998 | K982305 | SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT | DZE | Substantially Equivalent | Sulzer Calcitek, Inc. | accessdata.fda.gov |
| August 26, 1997 | K972444 | 3I INNOVATIVE IMPLANTS AND COVER SCREWS | DZE | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| June 23, 1997 | K970752 | SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM | DZE | Substantially Equivalent | Sulzer Calcitek, Inc. | accessdata.fda.gov |
| August 29, 1996 | K962106 | SPLINE DENTAL IMPLANT SYSTEMS | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| March 8, 1996 | K955619 | 5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| February 8, 1996 | K960021 | CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| February 8, 1996 | K943604 | INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| December 21, 1995 | K953101 | PARAGON IMPLANT SYSTEM | DZE | Substantially Equivalent | Core-Vent Bio-Engineering, Inc. | accessdata.fda.gov |
| May 16, 1995 | K944327 | INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| May 27, 1994 | K932123 | IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM | DZE | Substantially Equivalent | Implant Innovations International, Inc. | accessdata.fda.gov |
| April 26, 1994 | K933969 | TAPERED ABUTMENT AND RELATED COMPONENTS | DZE | Substantially Equivalent | Implant Innovations, Inc. | accessdata.fda.gov |
| November 5, 1993 | K932274 | INTEGRAL III DENTAL IMPLANT ABUTMENT | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| February 11, 1992 | K912059 | PRE-ANGLED ABUTMENTS | DZE | Substantially Equivalent | Core-Vent Corp. | accessdata.fda.gov |
| February 20, 1991 | K900179 | SCREW-VENT ENDOSSEOUS IMPLANT ABUTMENTS | DZE | Substantially Equivalent | Core-Vent Corp. | accessdata.fda.gov |
| February 11, 1991 | K900694 | CASTABLE ABUTMENTS | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| December 17, 1990 | K902969 | SCREW-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTS | DZE | Substantially Equivalent | Core-Vent Corp. | accessdata.fda.gov |
| November 9, 1990 | K904228 | OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED) | DZE | Substantially Equivalent | Collagen Corp. | accessdata.fda.gov |
| June 28, 1990 | K900549 | INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| June 22, 1990 | K900545 | O-RING PROSTHETIC ATTACHMENT DEVICE | DZE | Substantially Equivalent | Calcitek, Inc. | accessdata.fda.gov |
| October 10, 1989 | K891613 | OVERDENTURE ATTACHMENT | DZE | Substantially Equivalent | Implant Innovations International, Inc. | accessdata.fda.gov |
| September 1, 1989 | K883717 | BIO-VENT | DZE | Substantially Equivalent | Core-Vent Corp. | accessdata.fda.gov |
| July 10, 1987 | K871863 | ADBUTMENT CYLINDER AND SCREW | DZE | Substantially Equivalent | Implant Innovations International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Bone Grafting Material, Human Source
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Tray, Surgical, Instrument
- All makers of Attachment, Precision, All
Updated October 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.