ZimVie Spain S.L.U.

FDA Device Registration & Listing · Cornella de Llobregat Barcelona, ES · Registration 3006411780

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006411780
FEI Number
3006411780
Entity Name
ZimVie Spain S.L.U.
City/State/Country
Cornella de Llobregat Barcelona, ES
Establishment Address
WTC Almeda Park, Ed.4, Planta 2, C/Tirso de Molina, 40, Cornella de Llobregat Barcelona 08940, ES
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
ZimVie US Corp LLC (Owner Number: 1038806)
Owner / Operator Contact Address
4555 Riverside Drive, --, Palm Beach Gardens, FL 33410, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K061847
PMA Number
N/A

All Registered 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 Tapered Screw-Vent BellaTek® Patient Specific Abutment System BELLATEK® TIN ABUTMENT BELLATEK® TITANIUM ABUTMENT CERTAIN® BELLATEK® TIN ABUTMENT Immediate Molar Implants Spline Twist Integral and Omnoloc Gold Copinig CERTAIN® BELLATEK® TITANIUM ABUTMENT BELLATEK® TIN ABUTMENT BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS ENCODE ABUTMENT Tapered Screw-Vent Screw-Vent Endosseous Implant Abutm TSV BellaTek Encode Healing Abutment Spline Twist Tapered Screw-Vent OSSEOTITE 2 Implant Hex-Lock 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 Spline Twist 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 Tapered Screw-Vent Spline Dental Implant System OSSEOTITE Certain PREVAIL Implant OSSEOTITE Certain PREVAIL 2 Implant Tapered Screw-Vent TSX Implants Prep-Tite Post Tapered Screw-Vent Certain PreFormance Post Certain PreFormance Pre-Angled Post Dental Accessories for Spline, Advent, SwissPlus and Tapered Screw Vent Dental Implant SystemsDental Accessories for Spl Tapered Screw-Vent 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 Trabecular Metal Spline Transfer Coping Screw Tapered Screw-Vent ZIMMER BIOMET BELLATEK ABUTMENT FOR USE WITH ZIMMER IMPLANT SYSTEMS, ZIRCONIA ZIMMER ZFX ABUTMENT FOR USE WITH ZIMMER IMPLANT SYSTEMS, ZIRCONIA Zimmer ZFX

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-07-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-07-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2009-12-14
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-09-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-12-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2008-03-31
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2008-05-30
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-09-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-12-21
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2008-07-24
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-12-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2007-10-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2011-09-27
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-12-21
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-07-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-06-11
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2007-10-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-07-03
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-07-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2008-03-31
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-12-28
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-09-25
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-01-06
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-01-31
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-08-05
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-12-15
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2008-03-17
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-04-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-06-11
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-12-21
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-08-05
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-12-22
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-12-28
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-07-11
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-12-29
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-06-11
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-10-24
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-07-11
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-12-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-06-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-02-20
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-12-28
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-08-05
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2018-01-25
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-07-11
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-12-15
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-12-29
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-12-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2011-12-21
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-12-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-08-16
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2015-10-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-01-06
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2009-12-14
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-07-11
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2015-11-23
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-04-04
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-12-28
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-07-11
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-08-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-12-22
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-09-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2015-09-23
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-12-28
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2009-12-14
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2002-11-26
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-07-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-01-05
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-12-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2007-10-22
EGG Attachment, Precision, All Dental Class 1 872.3165 1993-12-29
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2009-12-14
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2017-07-11
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-08-05
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-07-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-12-12
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-12-15

Official Correspondent

Ruth Lopez

US Agent Details

Henrique Nomelini Muniz Business: ZimVie US Corp LLC Email: 3ipbg-Regulatoryaffairs@Zimvie.com Phone: (561) 7766700

Related Public Records

Same Entity

ZimVie US Corp LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3008932779 Zfx GmbH Dachau Bavaria, DE
1000244346 ZimVie Canada Inc. Mississauga Ontario, CA
3009840806 ZimVie Spain S.L.U. Paterna Valencia, ES
1038806 ZimVie US Corp LLC Palm Beach Gardens, FL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K081806 Idi Biomedical, LLC IDI IMPLANT SYSTEM 2008-11-07
K120793 Z-Systems AG Z-LOOK3 EVO SLM 2012-12-21
K130140 Intra-Lock International INTRA-LOCK OP DENTAL IMPLANT 2013-08-01
K925778 Nobelpharma USA, Inc. BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES 1993-04-14
K903999 O Co., Inc. OBUTMENT HB 1992-02-11

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2020 Implant Direct Sybron Manufacturing, LLC 2
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026 S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil 2
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020 Implant Direct Sybron Manufacturing, LLC 2
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 2
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05 Implant Innovations, Inc. 2
EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006411780. Last updated year: 2026. Please use registration number 3006411780 when referencing this establishment in official correspondence.
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