Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009840806

FEI Number

3009840806

Entity Name

ZimVie Spain S.L.U.

City/State/Country

Paterna Valencia, ES

Establishment Address

c/Islas Baleares, 50, Pol. Ind. Fuente del Jarro, Paterna Valencia 46988, ES

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Eztetic Tapered Screw-Vent BellaTek Copymilled Bar Screw-Vent Endosseous Implant Abutm Immediate Molar Implants Prep-Tite Cap Prep-Tite Post T3 Pro Implants Conical Angled Abutment Certain Conical Angled Abutment PreFormance Pre-Angled Post PreFormance Post PreFormance Temporary Cylinder Non-Hexed PreFormance Temporary Cylinder Hexed Certain Prevail Dental Implants 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 NBA Titanium Abutment NBA TIN Abutment LDA Screw NBA Titanium Hexed Screw BellaTek Encode Emergence Healing Abutments Zimmer 3.1mm Eztetic Implant Gold Abutment Ti Prepable Abutment Certain PreFormance Temporary Cylinder Non-Hexed Certain PreFormance Temporary Cylinder Hexed 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 Screw-Vent TSX Implants Zimmer Zfx NobelReplace Abutment AdVent OSSEOTITE Certain 2 Implant Dal-Ro Abutment Dal-Ro Castable System Dal-Ro Housing - Female Assembly Dal-Ro Female Metal Dal-Ro Threaded Female Tapered SwissPlus Integral & Omniloc O-ring Attachment NanoTite Certain PREVAIL Implant NanoTite Certain Implant Provisional Coping BellaTek Abutment BellaTek Certain Titanium Abutment BellaTek Lab Designed Abutment BellaTek Certain TiN Abutment Spline Twist Spline Twist SwissPlus Tapered SwissPlus Hex-Lock 5 Spline Dental Implant System Tapered Screw-Vent GenTek Tapered SwissPlus Hex-Lock Tapered Screw-Vent 3i T3 Short External Hex Parallel Walled Implant 3i T3 Short External Hex Parallel Walled Implant with DCD TSV BellaTek Encode Healing Abutment 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 QuickBridge Cylinder and Cap QuickBridge Cap Tapered Screw-Vent Spline Twist Pre-Angled Abutments Zimmer ZFX BellaTek® Patient Specific Abutment System BELLATEK® TIN ABUTMENT BELLATEK® TITANIUM ABUTMENT CERTAIN® BELLATEK® TIN ABUTMENT Spline Dental Implant System Hex-Lock

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	2016-12-28
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-12-15
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	2012-06-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-08-05
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-10-24
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2015-10-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2015-09-23
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-04-01
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2008-03-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2008-03-31
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-03-31
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-12-01
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-12-14
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2012-09-25
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-09-20
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-12-21
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
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-12-22
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-12-22
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2008-03-31
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-01-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-12-15
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
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-08-05
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-12-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-04-18
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-01-06
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-11-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-07-11
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-12-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-01-06
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-05-30
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-12-01
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	2017-07-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-12-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-12-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-12-01
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-12-28
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-03-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-12-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-12-28
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2015-11-23
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-01-25
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-12-15
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-11-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2007-10-22
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2008-03-31
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-12-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-07-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-01-06
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	2012-06-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-01-06
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-07-11
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
3006411780	ZimVie Spain S.L.U.	Cornella de Llobregat Barcelona, 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 3009840806. Last updated year: 2026. Please use registration number 3009840806 when referencing this establishment in official correspondence.