FDA Registration Active 🇨🇦 Canada

ZimVie Canada Inc.

Reg #: 1000244346 · FEI: 1000244346 · Expires 2026
Products
7
Proprietary Names
248
Establishment Types
1
Classifications
7

Registration Details

Registration Name
ZimVie Canada Inc.
Registration Number
1000244346
FEI Number
1000244346
Status
Active
Expiry Year
2026
Initial Importer
No
Address
2345 Argentia Rd, Suite 106
City
Mississauga Ontario
Country
CA

Regulatory Submissions

510(k) Number
K970752

Owner / Operator

Firm Name
ZimVie US Corp LLC
Operator Number
1038806
Address
4555 Riverside Drive, --
City
Palm Beach Gardens
State
FL
Postal Code
33410
Country
US
Correspondent
Ruth Lopez

US Agent

Business Name
ZimVie US Corp LLC
Contact Name
Henrique Nomelini Muniz
Address
4555 Riverside Dr
City
Palm Beach Gardens
State
FL
ZIP
33410
Country
US
Phone
561 7766700

Products

Device Name Product Code
Implant, Endosseous, Root-Form DZE
Abutment, Implant, Dental, Endosseous NHA
Accessories, Implant, Dental, Endosseous NDP
Bone Grafting Material, Human Source NUN
Attachment, Precision, All EGG
Template HWT
Tray, Surgical, Instrument FSM

Proprietary Names

Spline Transfer Coping Screw Hex-Lock Tapered Screw-Vent PreFormance Pre-Angled Post PreFormance Post PreFormance Temporary Cylinder Non-Hexed PreFormance Temporary Cylinder Hexed Dental Accessories for Spline, Advent, SwissPlus and Tapered Screw Vent Dental Implant SystemsDental Accessories for Spl Pre-Angled Abutments RegenerOss Allograft Putty Certain PreFormance Post Certain PreFormance Pre-Angled Post OSSEOTITE XP Implant LTX Implant LTX XP Miniplant Cover Screw Headless Full OSSEOTITE Tapered Implant Full OSSEOTITE Implant Cover Screw Implant NanoTite Tapered Implant Implant Cover Screw OSSEOTITE Tapered Implant OSSEOTITE XP Miniplant OSSEOTITE Implant Full OSSEOTITE XP Miniplant NanoTite Implant Spline Twist 5 Spline Dental Implant System TSX Implants Integral and Omnoloc Gold Copinig 3i T3 Ex Hex Parallel Walled Implant 3i T3 with DCD Ex Hex Tapered Implant 3i T3 with DCD Ex Hex Parallel Walled Implant 3i T3 Ex Hex Tapered Implant Tapered SwissPlus Zimmer Zfx NobelReplace Abutment Pre-Angled Abutment Screw Pre-Angled Abutment Washer Pre-Angled Abutment NanoTite Certain PREVAIL Implant NanoTite Certain Implant Zimmer ZFX RegenerOss Allograft Putty Plus Mineralized BellaTek Encode Emergence Healing Abutments BellaTek Hader Bar BellaTek Primary Bar BellaTek Dolder Bar BellaTek Hybrid Bar Titanium Hexed Screw 3i T3 Short External Hex Parallel Walled Implant 3i T3 Short External Hex Parallel Walled Implant with DCD OSSEOTITE Certain 2 Implant CERTAIN® BELLATEK® TITANIUM ABUTMENT BELLATEK® TIN ABUTMENT BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS ENCODE ABUTMENT Spline Dental Imp Sys - Temp Abut Trabecular Metal Zimmer Biomet BellaTek® Abutment for Zimmer TAPERED SCREW-VENT® Implant Systems, Titanium Zimmer® Zfx™ Abutment for Zimmer TAPERED SCREW-VENT® Implant Systems, Titanium Certain LOCATOR Abutment LOCATOR Extra Light Angle Replacement LOCATOR Replacement Housing Kit LOCATOR Replacement Males LOCATOR Attachment LOCATOR Abutment LOCATOR Extra Light Retention Males LOCATOR Extended Range Males LOCATOR Light Retention Replacement Males LOCATOR Replacement Housing BellaTek® Patient Specific Abutment System BELLATEK® TITANIUM ABUTMENT CERTAIN® BELLATEK® TIN ABUTMENT Zimmer 3.1mm Eztetic Implant Gold Abutment BellaTek Copymilled Bar Certain Prevail Dental Implants Conical Temporary Cylinder Hexed Certain UCLA Gold Non-Hexed Abutment Certain Temporary Non-Hexed Cylinder Standard Abutment Gold Cylinder Conical EP Healing Cap UCLA Gold MicroMini Hexed Abutment Cylinder Certain UCLA Gold Hexed Abutment Cylinder Certain UCLA Gold Non-Hexed Abutment Cylinder UCLA Gold Standard ZR Hexed Abutment Cylinder Conical Gold Cylinder Non-Hexed Certain GingiHue Post IOL Gold Cylinder Certain Temporary Hexed Cylinder Conical Abutment Gold Standard ZR Chamfered Gold Cylinder for Standard Abutment Certain UCLA Gold Hexed Abutment UCLA Gold Non-Hexed Abutment Cylinder Conical Titanium Cylinder Non-Hexed Temporary Cylinder Titanium Square UniScrew IOL Distal Extension EP Healing Abutment Healing Abutment GingiHue Post Certain Gold-Tite Hexed Screw Conical EP Temporary Cylinder Non-Hexed Conical Abutment Certain UCLA Titanium Non-Hexed Abutment Conical EP Temporary Cylinder Hexed Temporary Cylinder with Hexed Screw Temporary Healing Cylinder Standard Abutment Gold-Tite Hexed Retaining Screw Conical Healing Cap EP Healing Abutment Abutment Post UCLA Gold Hexed Abutment Cylinder UCLA Gold Abutment Non-Hexed Cylinder GingiHue Pre-Angled Post Certain Conical Abutment IOL Healing Cap Two piece EP Healing Abutment IOL Abutment and Screw Certain ZiReal POST Gold-Tite Hexed Abutment Screw Temporary Cylinder - Standard Abutment BellaTek Encode Healing Abutment Conical Castable Cylinder Non-Hexed Conical Temporary Cylinder Non-Hexed Temporary Hexed Implant Cylinder with Hexed Screw Certain Straight Healing Abutment Gold-Tite Hexed UniScrew UCLA Gold Abutment Hexed Cylinder Conical Castable Cylinder Hexed Certain UCLA Gold Non-Hexed Cylinder UCLA Gold Non-Hexed Abutment Temporary Hexed Cylinder with Retention Conical Gold Cylinder Hexed Certain IOL Abutment Temporary Non-Hexed Implant Cylinder with Hexed Screw Implant Temporary Hexed Cylinder with Hex Screw Certain EP Healing Abutment Certain Conical Abutment Screw Titanium Hexed UniScrew Certain Titanium Hexed Screw IOL Titanium Temporary Cylinder Standard Abutment Temporary Screw Standard Abutment Castable Plastic Cylinder Certain BellaTek Encode Healing Abutment Certain Provide Abutment Temporary Non-Hexed Cylinder With Retention UCLA Titanium Non-Hexed Abutment Cylinder Implant Temporary Non-Hexed Cylinder with Hex Screw Gold-Tite Square UniScrew Certain Standard Abutment Eztetic Standard Abutment Titanium Screw Conical Abutment Screw TSV BellaTek Encode Healing Abutment OSSEOTITE 2 Implant NBR Titanium Abutment LDA Screw NBR NBR TIN Abutment One-piece Implant, 3mm Angled Certain PreFormance Temporary Cylinder Non-Hexed Certain PreFormance Temporary Cylinder Hexed One -piece Implant System BellaTek Abutment BellaTek Certain Titanium Abutment BellaTek Lab Designed Abutment BellaTek Certain TiN Abutment Prep-Tite Post T3 Pro Implants 3i T3 with DCD Non-Platform Switched Parallel Walled Implant 3i T3 Parallel Walled Implant 3i T3 Non-Platform Switched Tapered Implant 3i T3 with DCD Tapered Implant 3i T3 Tapered Implant 3i T3 with DCD Parallel Walled Implant 3i T3 with DCD Non-Platform Switched Tapered Implant 3i T3 Non-Platform Switched Parallel Walled Implant Ti Prepable Abutment Gold Hader Type Clip Plastic Hader Type Clip Certain Gold-Tite Large Hexed Screw Certain Titanium Large Hexed Screw Spline Dental Implant System Certain Cover Screw Full OSSEOTITE Certain Implant OSSEOTITE Certain Implant Certain MicroMini Flat Implant Cover Screw Certain Implant Straight Cover Screw Full OSSEOTITE XP Certain Implant Certain Flat Implant Cover Screw Certain Implant Headless Cover Screw Certain Implant Cover Screw NanoTite Tapered Certain Implant Full OSSEOTITE Tapered Certain Implant Certain PREVAIL Implant OSSEOTITE Tapered Certain Implant OSSEOTITE XP Certain Implant Prep-Tite Cap SwissPlus Conical Angled Abutment Certain Conical Angled Abutment Low Profile Abutment Hexed Castable Cylinder Low Profile Abutment Distal Extension Low Profile One-Piece Abutment Low Profile Abutment Non-Hexed Gold Cylinder Low Profile Abutment Non-Hexed Temporary Cylinder Low Profile Abutment Laser Weld Cylinder Low Profile Abutment Titanium Retaining Screw Low Profile Abutment Healing Cap Low Profile Abutment Gold-Tite Retaining Screw Low Profile Abutment Hexed Gold Cylinder Low Profile Abutment QuickBridge Low Profile Abutment Hexed PreFormance Temporary Cylinder Low Profile Abutment Certain Low Profile Abutment Low Profile Abutment QuickBridge Replacement Cap Low Profile Abutment Non-Hexed Castable Cylinder Low Profile Abutment Non-Hexed PreFormance Temporary Cylinder Certain Low Profile One-Piece Abutment Low Profile Abutment Hexed Temporary Cylinder ZIMMER BIOMET BELLATEK ABUTMENT FOR USE WITH ZIMMER IMPLANT SYSTEMS, ZIRCONIA ZIMMER ZFX ABUTMENT FOR USE WITH ZIMMER IMPLANT SYSTEMS, ZIRCONIA OSSEOTITE Certain PREVAIL Implant OSSEOTITE Certain PREVAIL 2 Implant Provisional Coping Radiographic Transparency Integral & Omniloc O-ring Attachment Certain BellaTek TiN Abutment BellaTek TiN Abutment BellaTek Titanium Abutment Certain BellaTek Titanium Abutment Certain BellaTek Express and BellaTek Flex Abutments Screw Vent Endosseus HA Coated Den SBL Titanium Abutment LDA Screw SBL SBL TIN Abutment QuickBridge Cylinder and Cap QuickBridge Cap NBA Titanium Abutment NBA TIN Abutment LDA Screw NBA Immediate Molar Implants Screw-Vent Endosseous Implant Abutm Dal-Ro Abutment Dal-Ro Castable System Dal-Ro Housing - Female Assembly Dal-Ro Female Metal Dal-Ro Threaded Female AdVent Bellatek Abutment TSV

Establishment Types

Export Device to the United States But Perform No Other Operation on Device