ZimVie US Corp LLC

Integral & Omniloc O-ring Attachment GenTek Tapered Screw-Vent OSSEOTITE Certain PREVAIL Implant OSSEOTITE Certain PREVAIL 2 Implant Ti Prepable Abutment BellaTek® Patient Specific Abutment System BELLATEK® TIN ABUTMENT BELLATEK® TITANIUM ABUTMENT CERTAIN® BELLATEK® TIN ABUTMENT Trabecular Metal QuickBridge Cylinder and Cap QuickBridge Cap Hex-Lock Dal-Ro Abutment Dal-Ro Castable System Dal-Ro Housing - Female Assembly Dal-Ro Female Metal Dal-Ro Threaded Female Bellatek Abutment TSV 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 Screw-Vent Endosseous Implant Abutm Spline Twist OSSEOTITE 2 Implant Spline Transfer Coping Screw Pre-Angled Abutments Burs for Spline, Advent, SwissPlus and Tapered Screw Vent Dental Implant Systems AdVent Dental Accessories for Spline, Advent, SwissPlus and Tapered Screw Vent Dental Implant SystemsDental Accessories for Spl CERTAIN® BELLATEK® TITANIUM ABUTMENT BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS ENCODE ABUTMENT Spline Dental Implant System SBL Titanium Abutment LDA Screw SBL SBL TIN Abutment NBR Titanium Abutment LDA Screw NBR NBR TIN Abutment NBA Titanium Abutment NBA TIN Abutment LDA Screw NBA SwissPlus Tapered SwissPlus 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 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 Zimmer Zfx NobelReplace Abutment Integral and Omnoloc Gold Copinig Pre-Angled Abutment Screw Pre-Angled Abutment Washer Pre-Angled Abutment 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 Certain PreFormance Post Certain PreFormance Pre-Angled Post BellaTek Encode Emergence Healing Abutments BellaTek Hader Bar BellaTek Primary Bar BellaTek Dolder Bar BellaTek Hybrid Bar NanoTite Certain PREVAIL Implant NanoTite Certain Implant One-piece Implant, 3mm Angled Screw Vent Endosseus HA Coated Den Conical Angled Abutment Certain Conical Angled Abutment TSX Implants RegenerOss Allograft Putty Plus Mineralized BellaTek Copymilled Bar PreFormance Pre-Angled Post PreFormance Post PreFormance Temporary Cylinder Non-Hexed PreFormance Temporary Cylinder Hexed ZIMMER BIOMET BELLATEK ABUTMENT FOR USE WITH ZIMMER IMPLANT SYSTEMS, ZIRCONIA ZIMMER ZFX ABUTMENT FOR USE WITH ZIMMER IMPLANT SYSTEMS, ZIRCONIA Zimmer ZFX UCLA TI Cylinder UCLA Castable Abutments/Cylinders Terrats Competitive Connection Abutments 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 3.1mm Eztetic Implant Gold Abutment Standard Abutment Titanium Screw Conical Abutment Screw Titanium Hexed Screw 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 One -piece Implant System 3i T3 Short External Hex Parallel Walled Implant 3i T3 Short External Hex Parallel Walled Implant with DCD 5 Spline Dental Implant System Immediate Molar Implants Certain BellaTek Express and BellaTek Flex Abutments Zimmer Biomet BellaTek® Abutment for Zimmer TAPERED SCREW-VENT® Implant Systems, Titanium Zimmer® Zfx™ Abutment for Zimmer TAPERED SCREW-VENT® Implant Systems, Titanium Gold Hader Type Clip Plastic Hader Type Clip 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 T3 Pro Implants Certain Prevail Dental Implants Radiographic Transparency Certain Gold-Tite Large Hexed Screw Certain Titanium Large Hexed Screw Eztetic Spline Dental Imp Sys - Temp Abut Prep-Tite Cap Certain PreFormance Temporary Cylinder Non-Hexed Certain PreFormance Temporary Cylinder Hexed RegenerOss Allograft Putty BellaTek Abutment BellaTek Certain Titanium Abutment BellaTek Lab Designed Abutment BellaTek Certain TiN Abutment OSSEOTITE Certain 2 Implant Prep-Tite Post Certain BellaTek TiN Abutment BellaTek TiN Abutment BellaTek Titanium Abutment Certain BellaTek Titanium Abutment TSV BellaTek Encode Healing Abutment Provisional Coping

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Manufacture Device in the United States for Export Only