Manufacturer registered with FDA

ZimVie US Corp LLC

Palm Beach Gardens, FL, United States. Lists 7 dental device types with FDA across 5 registered establishments, and holds 1 510(k) clearance as applicant.

FDA owner/operator1038806Contract manufacturerManufacturer for exportForeign exporterManufacturer1 clearance in five years

Device types listed: 7
Brands and models: 254
510(k) clearances: 12026–2026
Markets registered in: 121,155 registrations outside the US
Establishments: 5Canada, Germany, Spain +1

510(k) clearances per year, 2007–2026

Registered in 12 markets

Where regulators' registries name ZimVie US Corp LLC as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	ZimVie US Corp LLC	1 clearances	2026–2026	Below
Canada	Health Canada	Registration holder	ZIMVIE US CORP LLC.	611	1999–2026	Pure Global AI
United Kingdom	MHRA	Manufacturer	ZimVie US Corp LLC	179	—	Pure Global AI
Colombia	INVIMA	Registration holder	ZIMVIE US CORP LLCZIMVIE SPAIN S.L.U. · ZFX GMBH	90	—	Pure Global AI
Costa Rica	Ministerio de Salud	Manufacturer	ZimVie US Corp LLCZimVie Spain S.L.U	80	—	Pure Global AI
Australia	TGA	Manufacturer	ZimVie US Corp LLC	49	2004–2023	Pure Global AI
Serbia	ALIMS	Manufacturer	ZimVie US Corp LLC	47	2022–2026	Pure Global AI
European Union	EUDAMED	Registration holder	ZimVie US Corp LLCZfx GmbH	41	—	Pure Global AI
Taiwan	TFDA	Manufacturer	ZimVie US Corp LLCZimVie Spain S.L.U.	28	2003–2025	Pure Global AI
China	NMPA	Registration holder	ZimVie US Corp LLC. 皆美美国有限责任公司ZimVie Us Corp LLC. 皆美美国有限责任公司 · ZimVie US Corp LLC.皆美美国有限责任公司 · +2	20	—	Pure Global AI
Israel	AMAR	Manufacturer	Zfx GmbHZimVie US Corp, LLC · ZimVie Us Corp LLC	7	—	Pure Global AI
Brazil	ANVISA	Manufacturer	ZFX GMBH	3	2024–2025	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What ZimVie US Corp LLC currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Root-Form Endosseous ImplantDZE · Class 2	Dental implants	Maker	AdVentBellatek Abutment TSVCertain Cover ScrewCertain Flat Implant Cover ScrewCertain Gold-Tite Large Hexed ScrewCertain Implant Cover ScrewCertain Implant Headless Cover ScrewCertain Implant Straight Cover ScrewCertain LOCATOR AbutmentCertain MicroMini Flat Implant Cover Screw 87 more Certain Prevail Dental ImplantsCertain PREVAIL ImplantCertain Titanium Large Hexed ScrewConical Abutment ScrewCover Screw HeadlessCover Screw ImplantDal-Ro AbutmentDal-Ro Castable SystemDal-Ro Female MetalDal-Ro Housing - Female AssemblyDal-Ro Threaded FemaleEzteticFull OSSEOTITE Certain ImplantFull OSSEOTITE ImplantFull OSSEOTITE Tapered Certain ImplantFull OSSEOTITE Tapered ImplantFull OSSEOTITE XP Certain ImplantFull OSSEOTITE XP MiniplantHex-LockImmediate Molar ImplantsImplant Cover ScrewIntegral & Omniloc O-ring AttachmentIntegral and Omnoloc Gold CopinigLOCATOR AbutmentLOCATOR AttachmentLOCATOR Extended Range MalesLOCATOR Extra Light Angle ReplacementLOCATOR Extra Light Retention MalesLOCATOR Light Retention Replacement MalesLOCATOR Replacement HousingLOCATOR Replacement Housing KitLOCATOR Replacement MalesLTX ImplantLTX XP MiniplantNanoTite Certain ImplantNanoTite Certain PREVAIL ImplantNanoTite ImplantNanoTite Tapered Certain ImplantNanoTite Tapered ImplantOne -piece Implant SystemOne-piece Implant, 3mm AngledOSSEOTITE 2 ImplantOSSEOTITE Certain 2 ImplantOSSEOTITE Certain ImplantOSSEOTITE Certain PREVAIL 2 ImplantOSSEOTITE Certain PREVAIL ImplantOSSEOTITE ImplantOSSEOTITE Tapered Certain ImplantOSSEOTITE Tapered ImplantOSSEOTITE XP Certain ImplantOSSEOTITE XP ImplantOSSEOTITE XP MiniplantPre-Angled AbutmentPre-Angled Abutment ScrewPre-Angled Abutment WasherPre-Angled AbutmentsPrep-Tite CapPrep-Tite PostScrew Vent Endosseus HA Coated DenScrew-Vent Endosseous Implant AbutmSpline Dental Imp Sys - Temp AbutSpline Dental Implant SystemSpline Transfer Coping ScrewSpline TwistStandard Abutment Titanium ScrewSwissPlusT3 Pro ImplantsTapered Screw-VentTapered SwissPlusTitanium Hexed ScrewTrabecular MetalTSX Implants3i T3 Ex Hex Parallel Walled Implant3i T3 Ex Hex Tapered Implant3i T3 Non-Platform Switched Parallel Walled Implant3i T3 Non-Platform Switched Tapered Implant3i T3 Parallel Walled Implant3i T3 Short External Hex Parallel Walled Implant3i T3 Short External Hex Parallel Walled Implant with DCD3i T3 Tapered Implant3i T3 with DCD Ex Hex Parallel Walled Implant3i T3 with DCD Ex Hex Tapered Implant3i T3 with DCD Non-Platform Switched Parallel Walled Implant3i T3 with DCD Non-Platform Switched Tapered Implant3i T3 with DCD Parallel Walled Implant3i T3 with DCD Tapered Implant5 Spline Dental Implant System	2007
Endosseous Dental Implant AbutmentNHA · Class 2	Implant abutments	Maker	Abutment PostBellaTek AbutmentBellaTek Certain TiN AbutmentBellaTek Certain Titanium AbutmentBellaTek Copymilled BarBellaTek Dolder BarBellaTek Encode Emergence Healing AbutmentsBellaTek Encode Healing AbutmentBellaTek Hader BarBellaTek Hybrid Bar 141 more BellaTek Lab Designed AbutmentBellaTek Primary BarBellaTek TiN AbutmentBellaTek Titanium AbutmentBellaTek® Patient Specific Abutment SystemBELLATEK® TIN ABUTMENTBELLATEK® TITANIUM ABUTMENTBIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS ENCODE ABUTMENTCertain BellaTek Encode Healing AbutmentCertain BellaTek Express and BellaTek Flex AbutmentsCertain BellaTek TiN AbutmentCertain BellaTek Titanium AbutmentCertain Conical AbutmentCertain Conical Abutment ScrewCertain Conical Angled AbutmentCertain EP Healing AbutmentCertain GingiHue PostCertain Gold-Tite Hexed ScrewCertain IOL AbutmentCertain Low Profile AbutmentCertain Low Profile One-Piece AbutmentCertain PreFormance PostCertain PreFormance Pre-Angled PostCertain PreFormance Temporary Cylinder HexedCertain PreFormance Temporary Cylinder Non-HexedCertain Provide AbutmentCertain Standard AbutmentCertain Straight Healing AbutmentCertain Temporary Hexed CylinderCertain Temporary Non-Hexed CylinderCertain Titanium Hexed ScrewCertain UCLA Gold Hexed AbutmentCertain UCLA Gold Hexed Abutment CylinderCertain UCLA Gold Non-Hexed AbutmentCertain UCLA Gold Non-Hexed Abutment CylinderCertain UCLA Gold Non-Hexed CylinderCertain UCLA Titanium Non-Hexed AbutmentCertain ZiReal POST Gold-Tite Hexed Abutment ScrewCERTAIN® BELLATEK® TIN ABUTMENTCERTAIN® BELLATEK® TITANIUM ABUTMENTChamfered Gold Cylinder for Standard AbutmentConical AbutmentConical Abutment Gold Standard ZRConical Angled AbutmentConical Castable Cylinder HexedConical Castable Cylinder Non-HexedConical EP Healing CapConical EP Temporary Cylinder HexedConical EP Temporary Cylinder Non-HexedConical Gold Cylinder HexedConical Gold Cylinder Non-HexedConical Healing CapConical Temporary Cylinder HexedConical Temporary Cylinder Non-HexedConical Titanium Cylinder Non-HexedEP Healing AbutmentGenTekGingiHue PostGingiHue Pre-Angled PostGold-Tite Hexed Retaining ScrewGold-Tite Hexed UniScrewGold-Tite Square UniScrewHealing AbutmentHex-LockImplant Temporary Hexed Cylinder with Hex ScrewImplant Temporary Non-Hexed Cylinder with Hex ScrewIOL Abutment and ScrewIOL Distal ExtensionIOL Gold CylinderIOL Healing CapIOL Titanium Temporary CylinderLDA Screw NBALDA Screw NBRLDA Screw SBLLow Profile AbutmentLow Profile Abutment Distal ExtensionLow Profile Abutment Gold-Tite Retaining ScrewLow Profile Abutment Healing CapLow Profile Abutment Hexed Castable CylinderLow Profile Abutment Hexed Gold CylinderLow Profile Abutment Hexed PreFormance Temporary CylinderLow Profile Abutment Hexed Temporary CylinderLow Profile Abutment Laser Weld CylinderLow Profile Abutment Non-Hexed Castable CylinderLow Profile Abutment Non-Hexed Gold CylinderLow Profile Abutment Non-Hexed PreFormance Temporary CylinderLow Profile Abutment Non-Hexed Temporary CylinderLow Profile Abutment QuickBridgeLow Profile Abutment QuickBridge Replacement CapLow Profile Abutment Titanium Retaining ScrewLow Profile One-Piece AbutmentNBA TIN AbutmentNBA Titanium AbutmentNBR TIN AbutmentNBR Titanium AbutmentPre-Angled AbutmentPreFormance PostPreFormance Pre-Angled PostPreFormance Temporary Cylinder HexedPreFormance Temporary Cylinder Non-HexedProvisional CopingQuickBridge CapQuickBridge Cylinder and CapSBL TIN AbutmentSBL Titanium AbutmentStandard AbutmentStandard Abutment Castable Plastic CylinderStandard Abutment Gold CylinderStandard Abutment Temporary ScrewTapered Screw-VentTemporary CylinderTemporary Cylinder - Standard AbutmentTemporary Cylinder with Hexed ScrewTemporary Healing CylinderTemporary Hexed Cylinder with RetentionTemporary Hexed Implant Cylinder with Hexed ScrewTemporary Non-Hexed Cylinder With RetentionTemporary Non-Hexed Implant Cylinder with Hexed ScrewTerrats Competitive Connection AbutmentsTi Prepable AbutmentTitanium Hexed UniScrewTitanium Square UniScrewTSV BellaTek Encode Healing AbutmentTwo piece EP Healing AbutmentUCLA Castable Abutments/CylindersUCLA Gold Abutment Hexed CylinderUCLA Gold Abutment Non-Hexed CylinderUCLA Gold Hexed Abutment CylinderUCLA Gold MicroMini Hexed Abutment CylinderUCLA Gold Non-Hexed AbutmentUCLA Gold Non-Hexed Abutment CylinderUCLA Gold Standard ZR Hexed Abutment CylinderUCLA TI CylinderUCLA Titanium Non-Hexed Abutment CylinderZimmer 3.1mm Eztetic Implant Gold AbutmentZIMMER BIOMET BELLATEK ABUTMENT FOR USE WITH ZIMMER IMPLANT SYSTEMS, ZIRCONIAZimmer Biomet BellaTek® Abutment for Zimmer TAPERED SCREW-VENT® Implant Systems, TitaniumZimmer ZFXZIMMER ZFX ABUTMENT FOR USE WITH ZIMMER IMPLANT SYSTEMS, ZIRCONIAZimmer Zfx NobelReplace Abutment	2007
All Precision AttachmentEGG · Class 1	—	Maker	Gold Hader Type ClipPlastic Hader Type Clip	1993
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Maker	Dental Accessories for Spline, Advent, SwissPlus and Tapered Screw Vent Dental Implant SystemsDental Accessories for Spl	2002
Human Source Bone Grafting MaterialNUN · Class 2	Bone grafts & membranes	Maker	RegenerOss Allograft PuttyRegenerOss Allograft Putty Plus Mineralized	2012
Rebasing Repairing Relining Denture ResinEBI · Class 2	Denture resins & teeth	Lister	—	2017
Dental BurEJL · Class 1	Dental burs & diamonds	Maker	Burs for Spline, Advent, SwissPlus and Tapered Screw Vent Dental Implant Systems	2022

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names ZimVie US Corp LLC as the applicant, including filings under its other names.

Decided	510(k)	Device	Device type
21 Sep 2026	K260940	BellaTek Bars	NHA Endosseous Dental Implant Abutment

Also lists devices cleared under other names

ZimVie US Corp LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Zimmer Dental, Inc. (30), Biomet 3i, LLC (25), Implant Innovations, Inc. (13), Calcitek, Inc. (10), Sulzer Dental, Inc. (6), Core-Vent Corp. (6), Sulzer Calcitek, Inc. (4), Implant Innovations International, Inc. (3).

Decided	510(k)	Device	Applicant	Device type
23 Oct 2024	K241753	Immediate Molar Implants	Biomet 3i, LLC	DZE Root-Form Endosseous Implant
1 Mar 2024	K231915	Zfx Abutments	Zfx GmbH - A Company of Zimvie	NHA Endosseous Dental Implant Abutment
14 Sep 2022	K220978	TSX Implants	Biomet 3i, LLC	DZE Root-Form Endosseous Implant
28 Mar 2022	K213672	T3 Pro Implants	Biomet 3i, LLC	DZE Root-Form Endosseous Implant
21 Dec 2021	K212730	BellaTek Encode Emergence Healing Abutments	Biomet 3i, LLC	NHA Endosseous Dental Implant Abutment
9 Dec 2019	K192522	TSV BellaTek Express and BellaTek Flex Abutments	Biomet 3i, LLC	NHA Endosseous Dental Implant Abutment
2 Jul 2019	K183138	Certain BellaTek Express and BellaTek Flex Abutments	Biomet 3i, LLC	NHA Endosseous Dental Implant Abutment
13 Dec 2017	K173374	TSV BellaTek Encode Healing Abutments	Biomet 3i, LLC	NHA Endosseous Dental Implant Abutment
20 Nov 2015	K150571	3i T3 Short Implants	Biomet 3i, LLC	DZE Root-Form Endosseous Implant
25 Jun 2015	K143505	Zimmer Patient-Specific Abutment, Internal Hex, Titanium	Zimmer Dental, Inc.	NHA Endosseous Dental Implant Abutment
1 May 2015	K143528	Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System	Zimmer Dental, Inc.	NHA Endosseous Dental Implant Abutment
21 Jan 2015	K142572	Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System	Zimmer Dental, Inc.	NHA Endosseous Dental Implant Abutment
28 Oct 2014	K142082	ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT	Zimmer Dental, Inc.	DZE Root-Form Endosseous Implant
16 Jun 2014	K140570	CHAIRSIDE ATTACHMENT PROCESSING MATERIAL	Zest Anchors, LLC	EBI Rebasing Repairing Relining Denture Resin
4 Mar 2014	K133339	ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED	Zimmer Dental, Inc.	DZE Root-Form Endosseous Implant
8 Jan 2014	K133049	3I T3(R) EXTERNAL HEX DENTAL IMPLANTS	Biomet 3i, LLC	DZE Root-Form Endosseous Implant
19 Nov 2013	K132258	ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM	Zimmer Dental, Inc.	DZE Root-Form Endosseous Implant
30 Jul 2013	K130949	CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS	Biomet 3i, LLC	DZE Root-Form Endosseous Implant
30 Jan 2013	K122300	T3 DENTAL IMPLANT	Biomet 3i, LLC	DZE Root-Form Endosseous Implant
8 Nov 2012	K120873	ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM	Zimmer Dental, Inc.	NHA Endosseous Dental Implant Abutment
11 Sep 2012	K120776	ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION	Biomet 3i, LLC	NHA Endosseous Dental Implant Abutment
30 Aug 2012	K113753	ZIMMER DENTAL TAPERED SCREW-VENT X	Zimmer Dental, Inc.	DZE Root-Form Endosseous Implant
23 Jan 2012	K113092	ZIMMER CONTOUR PROVISIONAL COPING	Zimmer Dental, Inc.	NHA Endosseous Dental Implant Abutment
20 Jan 2012	K113645	REGENEROSS ALLOGRAFT PLUS MINERLIZED	Biomet Interpore Cross	NUN Human Source Bone Grafting Material
13 Jan 2012	K112730	ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION	Biomet 3i, LLC	NHA Endosseous Dental Implant Abutment
14 Dec 2011	K112160	TAPERED SCREW-VENT X IMPLANT	Zimmer Dental, Inc.	DZE Root-Form Endosseous Implant
8 Dec 2011	K111853	ANGLED TAPERED ABUTMENT	Zimmer Dental, Inc.	NHA Endosseous Dental Implant Abutment
6 Dec 2011	K111889	ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT	Zimmer Dental, Inc.	DZE Root-Form Endosseous Implant
18 Nov 2011	K111216	OSSEOTITE 2 DENTAL IMPLANTS	Biomet 3i, LLC	DZE Root-Form Endosseous Implant
1 Sep 2011	K110565	ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE	Biomet 3i, LLC	NHA Endosseous Dental Implant Abutment
11 Aug 2011	K111852	ANODIZED HEALING COLLAR	Zimmer Dental, Inc.	NHA Endosseous Dental Implant Abutment
1 Apr 2011	K100724	OSSEOTITE II MODEL XIFOSSXXX	Biomet 3i, LLC	DZE Root-Form Endosseous Implant
11 Mar 2011	K101608	BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS	Biomet 3i, LLC	NHA Endosseous Dental Implant Abutment
11 Mar 2011	K101607	BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS	Biomet 3i, LLC	NHA Endosseous Dental Implant Abutment
3 Dec 2010	K102209	ENCODE PATIENT SPECIFIC ABUTMENT	Biomet 3i, LLC	NHA Endosseous Dental Implant Abutment
8 Nov 2010	K101582	CAM STRUCTSURE BARS	Biomet 3i, LLC	NHA Endosseous Dental Implant Abutment
1 Oct 2010	K101880	TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT	Zimmer Dental, Inc.	DZE Root-Form Endosseous Implant
14 Sep 2010	K101977	TAPERED SCREW-VENT T IMPLANT	Zimmer Dental, Inc.	DZE Root-Form Endosseous Implant
15 Dec 2009	K093164	3.25 SPLINE TWIST IMPLANT, HA COATED	Zimmer Dental, Inc.	DZE Root-Form Endosseous Implant
30 Nov 2009	K092341	LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION	Biomet 3i, LLC	NHA Endosseous Dental Implant Abutment
3 Nov 2009	K092377	PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S	Zimmer Dental, Inc.	NHA Endosseous Dental Implant Abutment
30 Oct 2009	K092403	TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620	Zimmer Dental, Inc.	NHA Endosseous Dental Implant Abutment
7 Apr 2009	K090723	HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,	Zimmer Dental, Inc.	NHA Endosseous Dental Implant Abutment
23 Dec 2008	K083474	ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT	Zimmer Dental, Inc.	NHA Endosseous Dental Implant Abutment
19 Dec 2008	K082639	ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS	Zimmer Dental, Inc.	DZE Root-Form Endosseous Implant
25 Sep 2008	K080164	ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT	Zimmer Dental, Inc.	NHA Endosseous Dental Implant Abutment
21 Jul 2008	K080864	CAM STRUCTSURE PRECISION MILLED BARS	Biomet 3i, LLC	NHA Endosseous Dental Implant Abutment
20 Dec 2007	K072642	BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS	Biomet 3i, LLC	NHA Endosseous Dental Implant Abutment
3 Dec 2007	K072878	MODIFICATION TO: LOCATOR IMPLANT ANCHOR	Zest Anchors, LLC	NHA Endosseous Dental Implant Abutment
4 Oct 2007	K072589	TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16	Zimmer Dental, Inc.	DZE Root-Form Endosseous Implant
20 Sep 2007	K071439	ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM	Zimmer Dental, Inc.	DZE Root-Form Endosseous Implant
30 Aug 2007	K071551	QUICKBRIDGE TM CYLINDER AND CAP	Biomet 3i, LLC	NHA Endosseous Dental Implant Abutment
30 May 2007	K071235	ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13	Zimmer Dental, Inc.	DZE Root-Form Endosseous Implant
14 May 2007	K070147	INTERGRO ORAL	Biomet 3i, LLC	NUN Human Source Bone Grafting Material
30 Apr 2007	K063341	3I OSSEOTITE CERTAIN DENTAL IMPLANTS	Implant Innovations, Inc.	DZE Root-Form Endosseous Implant
24 Apr 2007	K063286	OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE	Implant Innovations, Inc.	DZE Root-Form Endosseous Implant
20 Mar 2007	K063403	CONICAL ANGLED ABUTMENT	Implant Innovations, Inc.	NHA Endosseous Dental Implant Abutment
23 Feb 2007	K061629	CERTAIN PREVAIL DENTAL IMPLANT	Implant Innovations, Inc.	DZE Root-Form Endosseous Implant
12 Oct 2006	K061847	ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S	Zimmer Dental, Inc.	NHA Endosseous Dental Implant Abutment
8 Sep 2006	K061410	SCREW-VENT IMPLANT SYSTEM, SV;TAPERED SCREW -VENT IMPLANT SYSTEM, TSV;ADVENT IMPLANT SYSTEM,AV;ZIMMER ONE-PIECE IMPLANT	Zimmer Dental, Inc.	DZE Root-Form Endosseous Implant
21 Jul 2006	K061969	PREFORMANCE POSTS AND TEMPORARY CYLINDERS	Implant Innovations, Inc.	NHA Endosseous Dental Implant Abutment
17 May 2006	K060880	ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C1	Zimmer Dental, Inc.	NHA Endosseous Dental Implant Abutment
27 Feb 2006	K060291	PREFORMANCE TEMPORARY CYLINDER	Implant Innovations, Inc.	NHA Endosseous Dental Implant Abutment
1 Feb 2006	K053170	PREFORMANCE POSTS	Implant Innovations, Inc.	NHA Endosseous Dental Implant Abutment
23 Jan 2006	K052997	ZIMMER DENTAL ONE-PIECE IMPLANT	Zimmer Dental, Inc.	DZE Root-Form Endosseous Implant
20 Oct 2005	K052648	MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS	Implant Innovations, Inc.	NHA Endosseous Dental Implant Abutment
13 Oct 2005	K052600	ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED)	Zimmer Dental, Inc.	NHA Endosseous Dental Implant Abutment
15 Sep 2005	K051461	3I OSSEOTITE DENTAL IMPLANTS	Implant Innovations, Inc.	DZE Root-Form Endosseous Implant
13 Nov 2002	K014050	HEX-LOCK TEMPORARY ABUTMENT	Sulzer Dental, Inc.	DZE Root-Form Endosseous Implant
19 Sep 2002	K022113	3I DENTAL IMPLANT ACCESSORIES	Implant Innovations, Inc.	DZE Root-Form Endosseous Implant
18 Jan 2002	K013494	3.75MM AND 5.0MM SPLINE TWIST IMPLANT	Sulzer Dental, Inc.	DZE Root-Form Endosseous Implant
19 Nov 2001	K013227	SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT	Sulzer Dental, Inc.	DZE Root-Form Endosseous Implant
28 Sep 2001	K012911	3I LOCATER ABUTMENT SYSTEM	Implant Innovations, Inc.	DZE Root-Form Endosseous Implant
25 Jun 2001	K011245	ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM	Sulzer Dental, Inc.	DZE Root-Form Endosseous Implant
21 May 2001	K011028	SCREW-VENT DENTAL IMPLANT SYSTEM	Sulzer Dental, Inc.	DZE Root-Form Endosseous Implant
15 May 2001	K011038	TAPER-LOCK DENTAL IMPLANT SYSTEM	Sulzer Dental, Inc.	DZE Root-Form Endosseous Implant
19 Jan 2001	K010073	SPLINE DENTAL IMPLANT SYSTEM	Sulzer Calcitek, Inc.	DZE Root-Form Endosseous Implant
8 Dec 2000	K002614	ADVENT IMPLANT SYSTEM	Core-Vent Corp.	DZE Root-Form Endosseous Implant
30 Oct 2000	K002188	SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D,	Core-Vent Corp.	DZE Root-Form Endosseous Implant
21 Jun 2000	K001786	TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG	Sulzer Calcitek, Inc.	DZE Root-Form Endosseous Implant
22 Sep 1998	K982305	SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT	Sulzer Calcitek, Inc.	DZE Root-Form Endosseous Implant
26 Aug 1997	K972444	3I INNOVATIVE IMPLANTS AND COVER SCREWS	Implant Innovations, Inc.	DZE Root-Form Endosseous Implant
23 Jun 1997	K970752	SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM	Sulzer Calcitek, Inc.	DZE Root-Form Endosseous Implant
29 Aug 1996	K962106	SPLINE DENTAL IMPLANT SYSTEMS	Calcitek, Inc.	DZE Root-Form Endosseous Implant
8 Mar 1996	K955619	5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS	Calcitek, Inc.	DZE Root-Form Endosseous Implant
8 Feb 1996	K960021	CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS	Calcitek, Inc.	DZE Root-Form Endosseous Implant
8 Feb 1996	K943604	INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM	Calcitek, Inc.	DZE Root-Form Endosseous Implant
21 Dec 1995	K953101	PARAGON IMPLANT SYSTEM	Core-Vent Bio-Engineering, Inc.	DZE Root-Form Endosseous Implant
16 May 1995	K944327	INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM	Calcitek, Inc.	DZE Root-Form Endosseous Implant
27 May 1994	K932123	IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM	Implant Innovations International, Inc.	DZE Root-Form Endosseous Implant
26 Apr 1994	K933969	TAPERED ABUTMENT AND RELATED COMPONENTS	Implant Innovations, Inc.	DZE Root-Form Endosseous Implant
5 Nov 1993	K932274	INTEGRAL III DENTAL IMPLANT ABUTMENT	Calcitek, Inc.	DZE Root-Form Endosseous Implant
11 Feb 1992	K912059	PRE-ANGLED ABUTMENTS	Core-Vent Corp.	DZE Root-Form Endosseous Implant
20 Feb 1991	K900179	SCREW-VENT ENDOSSEOUS IMPLANT ABUTMENTS	Core-Vent Corp.	DZE Root-Form Endosseous Implant
11 Feb 1991	K900694	CASTABLE ABUTMENTS	Calcitek, Inc.	DZE Root-Form Endosseous Implant
17 Dec 1990	K902969	SCREW-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTS	Core-Vent Corp.	DZE Root-Form Endosseous Implant
9 Nov 1990	K904228	OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED)	Collagen Corp.	DZE Root-Form Endosseous Implant
28 Jun 1990	K900549	INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEM	Calcitek, Inc.	DZE Root-Form Endosseous Implant
22 Jun 1990	K900545	O-RING PROSTHETIC ATTACHMENT DEVICE	Calcitek, Inc.	DZE Root-Form Endosseous Implant
10 Oct 1989	K891613	OVERDENTURE ATTACHMENT	Implant Innovations International, Inc.	DZE Root-Form Endosseous Implant
1 Sep 1989	K883717	BIO-VENT	Core-Vent Corp.	DZE Root-Form Endosseous Implant
10 Jul 1987	K871863	ADBUTMENT CYLINDER AND SCREW	Implant Innovations International, Inc.	DZE Root-Form Endosseous Implant
13 Apr 1984	K840750	HYDROXYLAPATITE COATED ENDOSSEOUS DENT	Calcitek, Inc.	DZE Root-Form Endosseous Implant

Registered establishments

Establishment	Location	What it does
Zfx GmbHFDA reg. 3008932779	Dachau Bavaria, Germany	Complaint file establishment, Manufacturer, Specification developer
ZimVie Canada Inc.FDA reg. 1000244346	Mississauga Ontario, Canada	Foreign exporter
ZimVie Spain S.L.U.FDA reg. 3006411780	Cornella de Llobregat Barcelona, Spain	Complaint file establishment
ZimVie Spain S.L.U.FDA reg. 3009840806	Paterna Valencia(Province), Spain	Contract manufacturer, Manufacturer
ZimVie US Corp LLCFDA reg. 1038806	Palm Beach Gardens, FL, United States	Complaint file establishment, Contract manufacturer, Manufacturer for export, Manufacturer, Repacker / relabeler, Specification developer

Other names on FDA records

Zfx GmbH · ZimVie Spain S.L.U. · ZimVie Canada Inc.

Sources

FDA establishment registration & device listing (search FDA, owner/operator 1038806). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.