FDA Registration Active 🇪🇸 Spain

ZimVie Spain S.L.U.

Reg #: 3006411780 · FEI: 3006411780 · Expires 2026
Products
6
Proprietary Names
246
Establishment Types
1
Classifications
6

Registration Details

Registration Name
ZimVie Spain S.L.U.
Registration Number
3006411780
FEI Number
3006411780
Status
Active
Expiry Year
2026
Initial Importer
No
Address
WTC Almeda Park, Ed.4, Planta 2, C/Tirso de Molina, 40
City
Cornella de Llobregat Barcelona
Country
ES

Regulatory Submissions

510(k) Number
K132258

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
Attachment, Precision, All EGG
Template HWT
Tray, Surgical, Instrument FSM

Proprietary Names

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

Establishment Types

Complaint File Establishment per 21 CFR 820.198