Manufacturer registered with FDA

Ivoclar Vivadent, AG

Amherst, NY, United States. Lists 37 dental device types with FDA across 11 registered establishments, and holds 94 510(k) clearances as applicant.

FDA owner/operator8010208Contract manufacturerForeign exporterManufacturerPrivate-label distributor5 clearances in five years

Device types listed: 37
Brands and models: 344
510(k) clearances: 942001–2026
Markets registered in: 1910,417 registrations outside the US
Establishments: 11Austria, Canada, Switzerland +5

510(k) clearances per year, 2000–2026

Registered in 19 markets

Where regulators' registries name Ivoclar Vivadent, AG 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	Ivoclar Vivadent, AG	94 clearances	2001–2026	Below
Colombia	INVIMA	Registration holder	IVOCLAR VIVADENT AGIVOCLAR VIVADENT AG. · IVOCLAR VIVADENT MANUFACTURING GMBH · +2	7,593	—	Pure Global AI
Canada	Health Canada	Registration holder	IVOCLAR VIVADENT AGIVOCLAR VIVADENT INC. · CANDULOR AG · +1	1,015	1998–2026	Pure Global AI
South Korea	MFDS	Manufacturer	Ivoclar Vivadent AGIvoclar Vivadent Manufacturing GmbH · Ivoclar Vivadent GmbH · +2	568	1998–2026	Pure Global AI
Taiwan	TFDA	Manufacturer	IVOCLAR VIVADENT AGIvoclar Vivadent Manufacturing GmbH · Ivoclar Vivadent Manufacturing Inc. · +2	338	2005–2026	Pure Global AI
Saudi Arabia	SFDA	Manufacturer	Ivoclar Vivadent AGIvoclar Vivadent Inc. · IVOCLAR VIVADENT, INC.	217	—	Pure Global AI
Japan	PMDA	Registration holder	Ｉｖｏｃｌａｒ　Ｖｉｖａｄｅｎｔ株式会社Ｉｖｏｃｌａｒ　Ｖｉｖａｄｅｎｔ　株式会社	121	2007–2026	Pure Global AI
Brazil	ANVISA	Registration holder	IVOCLAR VIVADENT LTDA.IVOCLAR VIVADENT AG · DSSM AG · +2	115	2002–2026	Pure Global AI
Australia	TGA	Registration holder	Ivoclar Vivadent Pty LtdIvoclar Vivadent AG · Candulor AG · +1	104	2004–2026	Pure Global AI
Serbia	ALIMS	Manufacturer	Ivoclar Vivadent AG	101	2022–2026	Pure Global AI
European Union	EUDAMED	Registration holder	Ivoclar Vivadent AGCandulor AG · DSSM AG	79	—	Pure Global AI
China	NMPA	Registration holder	义获嘉伟瓦登特公司Ivoclar Vivadent AG义获嘉伟瓦登特美国公司Ivoclar Vivadent,Inc. · Ivoclar Vivadent, Inc. 义获嘉伟瓦登特美国公司 · +2	60	—	Pure Global AI
Costa Rica	Ministerio de Salud	Manufacturer	IVOCLAR VIVADENT AGIvoclarVivadent AG	46	—	Pure Global AI
Peru	DIGEMID	Manufacturer	IVOCLAR VIVADENT AG	27	2007–2026	Pure Global AI
Israel	AMAR	Manufacturer	IVOCLAR VIVADENT AGIvoclar Vivadent AG · DSSM AG	12	—	Pure Global AI
United Kingdom	MHRA	Manufacturer	Candulor AG	7	—	Pure Global AI
Hong Kong	MDD	Manufacturer	Ivoclar Vivadent AG	5	2025–2026	Pure Global AI
Philippines	FDA Philippines	Registration holder	Ivoclar Vivadent, Inc.Ivoclar Vivadent Inc.	5	2025–2026	Pure Global AI
Tanzania	TMDA	Manufacturer	IVOCLAR VIVADENT AGIvoclar Vivadent GmbH	4	2024–2026	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 Ivoclar Vivadent, AG currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Porcelain PowderEIH · Class 2	Dental ceramics & zirconia	Maker	CAD/CAM CEREC Starter KitIPS Build-Up LiquidIPS ClassicIPS Classic Powder OpaquerIPS e.max CADIPS e.max CAD CERECIPS e.max CAD Cryst Glaze Paste FluoIPS e.max CAD CrystallIPS e.max CAD Crystall Glaze PasteIPS e.max CAD Crystall Glaze Spray 43 more IPS e.max CAD Crystall ShadesIPS e.max CAD Crystall StainsIPS e.max CAD for InLabIPS e.max CAD for PlanmillIPS e.max CAD HTIPS e.max CAD ImpulseIPS e.max CAD LTIPS e.max CAD MTIPS e.max CeramIPS e.max Ceram ArtIPS e.max Ceram Glaze SprayIPS e.max Ceram Intro KitIPS e.max Ceram PowerIPS e.max Ceram SelectionIPS e.max PressIPS e.max Press Abutment SolutionsIPS e.max Press HOIPS e.max Press HTIPS e.max Press LTIPS e.max Press MTIPS e.max Press MultiIPS e.max ZirCADIPS e.max ZirCAD for InlabIPS e.max ZirCAD for PlanMillIPS e.max ZirCAD MT discsIPS e.max ZirCAD MT Multi blocksIPS e.max ZirCAD PrimeIPS e.max ZirCAD Prime EstheticIPS e.max ZirconiaIPS Empress CAD for M-CenterIPS Empress CAD for PlanmillIPS Empress CAD for PrograMillIPS Empress StainingIPS EmpressCADIPS InLineIPS InLine OneIPS InLine System Powder OpaquerIPS IvocolorIPS Ivocolor Intro KitIPS Style CeramIPS Style Ceram OneIPS Style Ceram TranspaNexxZr+ Multi 2	2007
Resin Tooth Shade MaterialEBF · Class 2	Dental composites	Maker	Chairside Workflow 3D PrintingHeliomolarHeliomolar FlowHeliomolar Trans ShadesIPS Empress DirectIPS Empress Direct ColorIPS Empress Direct EffectIPS Empress Direct OpaqueMultilink AutomixMultilink Automix Try-In 34 more SR IvocronSR LinkSR Modelling LiquidSR NexcoSR Nexco LinerSR Nexco OpaquerSR Nexco PasteSR Nexco Retention FlowSR Nexco StainsStains for Resin Teeth finisherTetric 100 Bulk FillTetric 100 Bulk FlowTetric 100 FlowTetric 100 Flow 2Tetric 100 UniversalTetric 100 Universal 2Tetric CADTetric CAD for PlanMillTetric Evo-LineTetric Evo-Line System KitTetric Evo-Line Workshop KitTetric EvoCeramTetric EvoFlowTetric LineTetric plus 100 FillTetric plus 100 FlowTetric plus FillTetric plus FlowTetric PowerFillTetric PowerFlowTetric PrimeVariolink 100Variolink Esthetic DCVariolink Esthetic LC	1982
Teeth Plastic DentureELM · Class 2	Denture resins & teeth	Maker	BlueLineBonartic II NFC PlusBonSelect TCRCandulor Bonartic TCRCandulor brand denture teethCandulor brandsCandulor Physioset TCRCondyloform II NFCCondyloform II NFC PlusIvotion Dent 23 more PhysioSelect TCRPhysiostar NFCPhysioStar NFC PlusPREFERENCEPreference AnteriorPreference PosteriorSR GnathostarSR IvostarSR ORTHOLINGUAL DCLSR Ortholingual SSR Ortholingual S DCLSR ORTHOPLANE DCLSR OrthotypSR Orthotyp A-DSR Orthotyp DCLSR Orthotyp SSR Orthotyp S DCLSR Orthotyp S PESR VivodentSR Vivodent A-DSR VIVODENT DCLSR Vivodent S DCLSR Vivodent S PE	2004
Rebasing Repairing Relining Denture ResinEBI · Class 2	Denture resins & teeth	Maker	Aesthetic ColdAesthetic HotAesthetic Intensiv ColorAutoPlastAutoPlast MonomerAutoPlast PolymerBasePlastBasePlast MonomerBasePlast PolymerFibers 15 more IvoBase High ImpactIvoBase HybridIvotionIvotion BaseIvotion Base PrintIvotion BondProbase ColdProbase High Impact ColdProbase High Impact HotProbase HotSR IvocapSR Ivocap High ImpactTriplex ColdTriplex HotXPLEX	2004
Resin Tooth Bonding AgentKLE · Class 2	Bonding agents	Maker	Adhese 100Adhese 2Adhese 2 100Adhese UniversalAdhese Universal DCAdhese Universal kit VivaPenAdhese Universal Refill VivaPenAdhese Universal Test Pack VivaPenCention PrimerExcite F 5 more Excite F DSCHeliobondMonobond Etch & PrimeMonobond PlusSyntac	2007
Endosseous Dental Implant AbutmentNHA · Class 2	Implant abutments	Maker	Abutment Solutions for CEREC/InLab Starter KitIPS e.max CAD Abutment SolutionsIPS e.max CAD Abutment Solutions- extra systemsIPS e.max CAD CER/inLab LTIPS e.max Press Abutment SolutionsIPS e.max Press Abutment Solutions for Nobel BiocareTelio CAD Abutment Solutions Telio CAD A16Telio CAD Abutment Solutions- extra systems	2012
Resin Temporary Crown and BridgeEBG · Class 2	Temporary crown & bridge materials	Maker	SR IvocronSR LinkTelio CADTelio CAD discTelio CAD for CerecTelio CAD for PlanMillTelio CAD LT discsTelio InlayTelio OnlayTelioCAD for M-Center 1 more TelioCAD for Milling Center	2007
Dental CementEMA · Class 2	Dental cements	Maker	Multilink Hybrid Abutment Test PackMultilink Primer A + BMultilink SpeedSpeedCEM 100SpeedCem PlusTelio LinkZirCAD Cement	2007
Cavity VarnishLBH · Class 2	Sealants & varnishes	Maker	Adhese 100Adhese UniversalAdhese Universal DCAdhese Universal kit VivaPenAdhese Universal Refill VivaPenAdhese Universal Test Pack VivaPenCention PrimerCervitec FCervitec PlusFluor Protector S	2007
Pit and Fissure Sealant and ConditionerEBC · Class 2	Sealants & varnishes	Maker	Helioseal ClearHelioseal F PlusIPS Empress Direct Effect	2007
Impression MaterialELW · Class 2	Impression materials	Maker	AccuDent XD Syringe MaterialAccuDent XD Tray MaterialVirtualVirtual CADbite	2007
Ultraviolet Activator for PolymerizationEBZ · Class 2	Curing lights	Maker	Bluephase EasyCureBluephase G4Bluephase G4 100Bluephase PowerCure	2011
Dental Abutment Design Software for Dental LaboratoryPNP · Class 2	Dental design & orthodontic software	Maker	IPS e.max CAD Abutment Solutions- extra systemsTelio CAD Abutment Solutions- extra systems	2019
Resin Impression Tray MaterialEBH · Class 1	Impression trays	Maker	ProArt CAD Try-InSR-IVOLENSR-IVOLEN TRAY MATERIAL	2005
ArticulatorsEJP · Class 1	Articulators & facebows	Maker	Articulator CA 3STRATOS	2005
FacebowKCR · Class 1	Articulators & facebows	Maker	Bite ForkBite Fork SetCandulor Registration SetCRS-10UNIVERSAL TRANSFERBOWUNIVERSAL TRANSFERBOW SYSTEM (UTS)Universal Transferbow System (UTS) CAD	2005
Preformed Impression TrayEHY · Class 1	Impression trays	Maker	AccuDent XD Impression TrayAccuDent XD Tray AdhesiveCentric Tray	1990
Restorative and Impression Material SyringeEID · Class 1	Dental hand instruments	Maker	DispenserIntraoral TipsMixing CannulasMixing TipsMultilink ApplicatorRoot Canal TipsVariolink Application TipsVirtual DispenserVirtual TipsVivadent Applicator 2 more VivaPen Snap On CannulasZirCAD Cement Mixing Tips	2005
Porcelain TeethELL · Class 2	Dental ceramics & zirconia	Maker	Bonartic CTPhysioset CTSR Vivoperl	2007
Dental Hand InstrumentsDZN · Class 1	Dental hand instruments	Maker	Cavifil InjectorOptraSculpt InstrumentsOptraStick	2001
Ac-Powered Dental AmalgamatorEFD · Class 1	—	Maker	Silamat S6	2004
Intraoral Dental WaxEGD · Class 1	—	Maker	Aesthetic Wax	2007
Dental Retractor AccessoriesEIF · Class 1	Dental hand instruments	Maker	OptraGate 2OptraGate AssortmentOptraGate JuniorOptraGate Junior Assortment Blue & PinkOptraGate RegularOptraGate SmallOptraGate Small Assortment Blue & PinkOptraGate Test Pack	2015
Base Metal AlloyEJH · Class 2	Dental alloys	Maker	Colado NCd.SIGN 30Spartan Ceramic SolderSpartan Solder	2006
Amalgam AlloyEJJ · Class 2	—	Maker	ValiantValiant PhDValiant Sure-Cap	2007
Arch Tracing InkKZO · Class 1	—	Maker	Gnathometer- CADGnathometer-M	2017
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Maker	ProArt CAD Splint	2003
Resin Filling Material CoatingEBD · Class 2	—	Maker	IPS Empress Direct Effect	2015
Abrasive DiskEHJ · Class 1	Polishing & prophylaxis	Maker	OptraGlossPolitip	2001
Rubber DamEIE · Class 1	Rubber dam systems	Maker	OptraDam Plus	2001
Dental Instrument Depth GaugeEIL · Class 1	Dental hand instruments	Lister	Bite GaugeBite PlaneRim Former New	2019
Oral Cavity Abrasive Polishing AgentEJR · Class 1	Polishing & prophylaxis	Maker	ProxytVD Polishing Paste	2001
Resin ApplicatorKXR · Class 1	—	Maker	OptraSculptOptraSculpt Pad	2012
Alloy Other Noble MetalEJS · Class 2	Dental alloys	Maker	AquariusAquarius Ceramic SolderCapricorn 15d.SIGN 53d.SIGN 59d.SIGN 67d.SIGN 91ElektraEvolution LiteHarmony 2 13 more Harmony X-HardIS-64Laser C&B WhiteLaser C&B YellowLodestarMagentaSolarcast 20Special High Fusing White Ceramic SolderSuper Solder Ceramic SolderUniversal Solder 1015 WUniversal Solder PKFW-2W-3	2001
Gold-Based Noble Metal AlloyEJT · Class 2	Dental alloys	Maker	Academy GoldAcademy Gold XHAquarius HardBrite GoldCallisto 75 PdCallisto CPGCallisto Implant 33d.SIGN 96d.SIGN 98Golden Ceramic Solder 26 more Harmony C & B 55Harmony HardHarmony MediumHGPKF 1015 Y SolderHGPKF 1030 Y SolderHigh Fusing White Ceramic SolderHIgh Fusing Yellow Ceramic SolderLaser Ceramic WhiteLaser Ceramic YellowLaser Ceramic Yellow PdfLow Fusing White Gold SolderMaxigoldMaxigold KFMidigold 50MinigoldSpartan PlusWW-1W-5X-LXL-XYY-1.585 Fine Gold Solder.615 Fine Gold Solder.650 Fine Gold Solder	2001
Saliva Ejector MouthpieceDYN · Class 1	—	Maker	OptraGate Dry Control	2025
Heat Source for Bleaching TeethEEG · Class 1	Teeth whitening lights	Lister	VivaStyle Whitening LED Kit	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 Ivoclar Vivadent, AG as the applicant, including filings under its other names.

Decided	510(k)	Device	Device type
1 Jul 2026	K261485	Tetric plus Fill;Tetric plus Flow	EBF Resin Tooth Shade Material
10 Mar 2026	K253953	IPS e.max Zirconia	EIH Porcelain Powder
5 Mar 2026	K252450	Adhese 2	KLE Resin Tooth Bonding Agent
23 Feb 2024	K233995	Ivotion Base Print	EBI Rebasing Repairing Relining Denture Resin
7 Jun 2022	K210804	Adhese Universal DC, Cention Primer	KLE Resin Tooth Bonding Agent
20 Aug 2021	K211916	IPS e.max One	EIH Porcelain Powder
16 Nov 2020	K193193	Telio CAD Abutment Solutions- extra systems	NHA Endosseous Dental Implant Abutment
11 Feb 2020	K191453	Cervitec F	LBH Cavity Varnish
26 Aug 2019	K191382	IPS e.max CAD Abutment Solutions- extra systems	NHA Endosseous Dental Implant Abutment
29 Jul 2019	K190339	Helioseal F Plus	EBC Pit and Fissure Sealant and Conditioner
3 Jul 2019	K190272	Bluephase PowerCure	EBZ Ultraviolet Activator for Polymerization
14 Mar 2019	K183380	Tetric PowerFill	EBF Resin Tooth Shade Material
7 Jun 2018	K173573	Tetric CAD	EBF Resin Tooth Shade Material
4 Apr 2017	K163613	Bluephase Style 20i	EBZ Ultraviolet Activator for Polymerization
15 Dec 2016	K160798	IPS e.max® Press Abutment Solutions for Viteo Base Ti	NHA Endosseous Dental Implant Abutment
20 May 2016	K152103	IPS Style Ceram, IPS Style Ceram One, IPS Style Press	EIH Porcelain Powder
12 Apr 2016	K153753	TelioCAD Multi	EBG Resin Temporary Crown and Bridge
29 Oct 2015	K151894	IPS Ivocolor	EIH Porcelain Powder
21 Sep 2015	K151564	Telio CAD Abutment Solutions	NHA Endosseous Dental Implant Abutment
9 Jun 2015	K150393	TETRIC EVOFLOW BULK FILL	EBF Resin Tooth Shade Material
3 Apr 2015	K150164	Monobond Etch & Prime	KLE Resin Tooth Bonding Agent
3 Apr 2015	K143575	Accu-Dent XD Tray, Accu-Dent XD Syringe	ELW Impression Material
25 Nov 2014	K142389	Variolink Esthetic	EBF Resin Tooth Shade Material
8 Oct 2014	K131487	FLUOR PROTECTOR S	LBH Cavity Varnish
11 Feb 2014	K133318	ADHESE UNIVERSAL	KLE Resin Tooth Bonding Agent
14 Jan 2014	K132984	SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S	ELM Teeth Plastic Denture
31 Oct 2013	K132209	IPS E.MAX CAD ABUTMENT SOLUTIONS	NHA Endosseous Dental Implant Abutment
20 Aug 2013	K130436	MULTILINK HYBRID ABUTMENT CEMENT	EMA Dental Cement
31 Jan 2013	K123397	MULTILINK AUTOMIX	EBF Resin Tooth Shade Material
24 Jan 2013	K123304	SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO	EBF Resin Tooth Shade Material
18 Oct 2012	K120053	IPS E.MAX PRESS - ABUTMENT SOLUTIONS	NHA Endosseous Dental Implant Abutment
29 Aug 2012	K121230	IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE	EBF Resin Tooth Shade Material
27 Jul 2012	K121359	IPS 99 ONE AND IPS 99 CERAM	EIH Porcelain Powder
25 Jun 2012	K120134	IPS E.MAX PRESS MULTI	EIH Porcelain Powder
8 Jun 2012	K120432	TELIO CS CEM IMPLANT	EMA Dental Cement
14 May 2012	K120736	SR PHONARES II	ELM Teeth Plastic Denture
14 Oct 2011	K111958	TETRIC EVOCERAM BULK FILL	EBF Resin Tooth Shade Material
29 Aug 2011	K110756	BLUEPHASE STYLE	EBZ Ultraviolet Activator for Polymerization
13 Apr 2011	K103556	IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)	EIH Porcelain Powder
25 Feb 2011	K103528	IPS EMPRESS DIRECT FLOW	EBF Resin Tooth Shade Material
17 Feb 2011	K103391	IVOBASE HYBRID, IVOBASE HIGH IMPACT	EBI Rebasing Repairing Relining Denture Resin
14 Feb 2011	K103379	TELIO CS INLAY & TELIO CS ONLAY	EBG Resin Temporary Crown and Bridge
10 Mar 2010	K093744	EXCITE F AND EXCITE DSC	KLE Resin Tooth Bonding Agent
10 Mar 2010	K093708	TELIO CAD	EBG Resin Temporary Crown and Bridge
28 Jan 2010	K093331	SR PHONARES NHC	ELM Teeth Plastic Denture
17 Jul 2009	K090941	ADHESE ONE F	KLE Resin Tooth Bonding Agent
17 Jun 2009	K090704	MULTILINK IMPLANT	EBF Resin Tooth Shade Material
12 Jun 2009	K091020	BLUEPHASE 20I	EBZ Ultraviolet Activator for Polymerization
4 Jun 2009	K091019	SPEEDCEM	EMA Dental Cement
11 May 2009	K090826	MONOBOND PLUS	KLE Resin Tooth Bonding Agent
29 Apr 2009	K090701	EMPRESS DIRECT	EBF Resin Tooth Shade Material
21 Sep 2007	K072338	CERVITEC PLUS	LBH Cavity Varnish
30 Aug 2007	K071848	IPS INLINE POM SYSTEM	EIH Porcelain Powder
11 May 2007	K070646	ADHESE ONE	KLE Resin Tooth Bonding Agent
2 Nov 2006	K062713	ADHESIVE DC ACTIVATOR	KLE Resin Tooth Bonding Agent
5 Sep 2006	K061781	MULTILINK SPRINT	EMA Dental Cement
17 Jul 2006	K060891	VIRTUAL	ELW Impression Material
8 May 2006	K060565	CONDYLAFORM II NFC	ELM Teeth Plastic Denture
17 Apr 2006	K060365	APEXCAL	EJK Calcium Hydroxide Cavity Liner
14 Oct 2005	K051705	IPS E.MAX CAD/IPS E.MAX ZIRCAD	EIH Porcelain Powder
20 Sep 2005	K051782	BLUEPHASE 16I	EBZ Ultraviolet Activator for Polymerization
20 Dec 2004	K042846	SYSTEMP.LINK	EMA Dental Cement
17 Dec 2004	K042847	SYSTEMP.CEM	EMA Dental Cement
14 Dec 2004	K042820	SYSTEMP.C&B PLUS	EBG Resin Temporary Crown and Bridge
22 Nov 2004	K042848	FRC POSTEC PLUS	ELR Root Canal Post
9 Nov 2004	K042819	TETRIC EVOCERAM	EBF Resin Tooth Shade Material
19 Aug 2004	K041433	BRIGHT GOLD XH	EJS Alloy Other Noble Metal
19 May 2004	K040951	SR ADORO	EBG Resin Temporary Crown and Bridge
17 May 2004	K040795	MULTICORE HB; MULTICORE FLOW	EBF Resin Tooth Shade Material
15 Jan 2004	K033773	CONCEPT HP ADD-ON; CONCEPT HP ENAMEL	EBF Resin Tooth Shade Material
5 Dec 2003	K033520	BLUEPHASE	EBZ Ultraviolet Activator for Polymerization
5 Nov 2003	K032470	MULTILINK	EMA Dental Cement
17 Oct 2003	K030922	VIVASENS	LBH Cavity Varnish
26 Sep 2003	K032715	DW 296 #15 SOLDER	EJT Gold-Based Noble Metal Alloy
4 Sep 2003	K032493	ALEXANDER	EJT Gold-Based Noble Metal Alloy
15 Apr 2003	K030436	BIO UNIVERSAL	EJT Gold-Based Noble Metal Alloy
15 Apr 2003	K030435	BIOUNIVERSAL PKF	EJT Gold-Based Noble Metal Alloy
14 Feb 2003	K024094	4 SEASONS	EBF Resin Tooth Shade Material
2 Dec 2002	K023035	SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER	ELM Teeth Plastic Denture
18 Oct 2002	K022969	UNIVERSAL CERAMIC SOLDER	EJT Gold-Based Noble Metal Alloy
9 Oct 2002	K022811	W-5	EJT Gold-Based Noble Metal Alloy
28 Aug 2002	K013869	SR IVOCRON	EBG Resin Temporary Crown and Bridge
25 Jul 2002	K021892	BRIGHT GOLD	EJT Gold-Based Noble Metal Alloy
1 May 2002	K013802	FRC POSTEC	ELR Root Canal Post
17 Apr 2002	K020253	4 ALL (DW286A)	EJH Base Metal Alloy
29 Mar 2002	K020898	D.SIGN 15 (DW286 B)	EJH Base Metal Alloy
13 Mar 2002	K020183	PISCES PLUS (DW286 C)	EJH Base Metal Alloy
22 Feb 2002	K014042	D.SIGN 84	EJS Alloy Other Noble Metal
7 Feb 2002	K013929	HELIOMOLAR HB TRANSLUCENT SHADES	EBF Resin Tooth Shade Material
7 Feb 2002	K013809	D.SIGN 59	EJS Alloy Other Noble Metal
30 Jan 2002	K014082	D.SIGN 53, MODEL NA1012204	EJS Alloy Other Noble Metal
28 Jan 2002	K013584	EXCITE SELF ETCH	KLE Resin Tooth Bonding Agent
22 Oct 2001	K013277	ASTRALIS 7, MODEL 557545	EBZ Ultraviolet Activator for Polymerization
19 Oct 2001	K013275	ASTRALIS 10, MODELS # 559588, 561859	EBZ Ultraviolet Activator for Polymerization

Some of these clearances are listed with FDA today by another company: Sagemax Bioceramics, Inc. (1), Institut Straumann AG (1).

Also lists devices cleared under other names

Ivoclar Vivadent, AG 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: Ivoclar North America, Inc. (12), Dentsply Sirona, Inc. (5), Wieland Dental + Technik GmbH & Co. KG (3), Ivoclar USA, Inc. (2), Vivadent (Usa), Inc. (2), Voco GmbH (1), Sagemax Bioceramics, Inc. (1), Ivoclar Vivadent, Agin (1).

Decided	510(k)	Device	Applicant	Device type
8 May 2018	K180386	Meron Plus QM	Voco GmbH	EMA Dental Cement
16 Dec 2015	K152118	Zenostar MT, Zenostar Color Liquids	Wieland Dental + Technik GmbH & Co. KG	EIH Porcelain Powder
13 Aug 2015	K151142	IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID	Wieland Dental + Technik GmbH & Co. KG	EBI Rebasing Repairing Relining Denture Resin
5 Jan 2015	K142233	zenostar MO, Zenostar T, Zenostar VisualiZr	Wieland Dental + Technik GmbH & Co. KG	EIH Porcelain Powder
10 Feb 2014	K130991	NEXXZR(TM)T AND NEXXZR(TM)S	Sagemax Bioceramics, Inc.	EIH Porcelain Powder
29 Mar 2013	K124008	IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE	Ivoclar Vivadent, Agin	NHA Endosseous Dental Implant Abutment
6 Dec 2012	K122852	PHYSIOSTAR NFC	Candulor USA, Inc.	ELM Teeth Plastic Denture
26 Mar 2009	K083739	HYDRORISE AND HYDROSYSTEM	Dentsply Sirona, Inc.	ELW Impression Material
14 Mar 2008	K080130	OCCLUFAST CAD	Dentsply Sirona, Inc.	ELW Impression Material
28 Oct 2002	K022653	ELITE MONOPHASE	Dentsply Sirona, Inc.	ELW Impression Material
27 Aug 2001	K012174	ERIS LAYERING MATERIALS	Ivoclar North America, Inc.	EIH Porcelain Powder
13 Dec 1999	K993783	TETRIC FLOW	Ivoclar North America, Inc.	EBF Resin Tooth Shade Material
8 Sep 1998	K982616	IPS EMPRESS 2	Ivoclar North America, Inc.	EIH Porcelain Powder
11 May 1998	K980986	PROCAD	Ivoclar USA, Inc.	EIH Porcelain Powder
1 Aug 1997	K972239	ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING	Dentsply Sirona, Inc.	ELW Impression Material
16 Jul 1997	K972027	ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)	Dentsply Sirona, Inc.	ELW Impression Material
22 Jan 1997	K964285	TETRIC CERAM	Ivoclar North America, Inc.	EBF Resin Tooth Shade Material
6 Aug 1996	K962456	SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH	Ivoclar North America, Inc.	ELM Teeth Plastic Denture
22 Jul 1994	K930835	VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A	Ivoclar North America, Inc.	ELL Porcelain Teeth
31 Jan 1992	K915377	SR-IVOCAP PLUS	Ivoclar North America, Inc.	EBI Rebasing Repairing Relining Denture Resin
17 Oct 1991	K913655	PROBASE HOT AND PROBASE COLD	Ivoclar North America, Inc.	EBI Rebasing Repairing Relining Denture Resin
26 Jun 1990	K901261	PV-CERAMIC, CERAMINIQUE	Ivoclar North America, Inc.	EIH Porcelain Powder
26 Jun 1990	K901913	SYNTAC (DENTIN BONDING AGENT)	Ivoclar North America, Inc.	KLE Resin Tooth Bonding Agent
16 Apr 1990	K896130	SR-IVOCAP	Ivoclar North America, Inc.	EBI Rebasing Repairing Relining Denture Resin
10 Jan 1990	K896132	ENAMEL PREP ENAMEL ETCHANT (EMAIL-PREPARATOR GS)	Ivoclar North America, Inc.	EBF Resin Tooth Shade Material
27 Jan 1989	K884588	HELIOMOLAR(R) DENTAL RESTORATIVE	Williams Dental Co., Inc.	EBF Resin Tooth Shade Material
10 Feb 1987	K864707	SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH	Ivoclar USA, Inc.	ELM Teeth Plastic Denture
11 Mar 1982	K820389	A DENTAL AMALGAM ALLOY (UNNAMED	Dentsply Intl., Inc.	EJJ Amalgam Alloy
2 Dec 1981	K813015	HELIOSEAL	Vivadent (Usa), Inc.	EBC Pit and Fissure Sealant and Conditioner
24 Nov 1980	K802681	HELIOBOND	Vivadent (Usa), Inc.	KLE Resin Tooth Bonding Agent
13 Aug 1980	K801690	VALIANT	L.D. Caulk Co.	EJJ Amalgam Alloy

Registered establishments

Establishment	Location	What it does
Candulor Dental GmbHFDA reg. 3011511773	Rielasingen-Worblingen Baden-Wurttemberg, Germany	Complaint file establishment, Specification developer
CANDULOR, AGFDA reg. 1000277456	Glattpark Zurich, Switzerland	Complaint file establishment, Contract manufacturer, Manufacturer, Private-label distributor, Specification developer
DSSM AGFDA reg. 3034244245	Schaan, Liechtenstein	Complaint file establishment
IVOCLAR VIVADENT AGFDA reg. 9612352	SCHAAN, Liechtenstein	Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer
Ivoclar Vivadent GmbHFDA reg. 3004966444	Ellwangen Baden-Wurttemberg, Germany	Foreign exporter, Repacker / relabeler
Ivoclar Vivadent Manufacturing GmbHFDA reg. 3003310824	NATURNO (BZ) Bolzano, Italy	Contract manufacturer
IVOCLAR VIVADENT Manufacturing GmbHFDA reg. 1000493628	BURS Vorarlberg, Austria	Contract manufacturer, Manufacturer
Ivoclar Vivadent Manufacturing, IncFDA reg. 2244842	Somerset, NJ, United States	Contract manufacturer, Repacker / relabeler
IVOCLAR VIVADENT, INC.FDA reg. 3009496224	Mississauga Ontario, Canada	Foreign exporter
IVOCLAR VIVADENT, INC.FDA reg. 3004362235	Lipa City Batangas, Philippines	Contract manufacturer, Foreign exporter, Repacker / relabeler
IVOCLAR VIVADENT, INC.FDA reg. 1316092	AMHERST, NY, United States	Complaint file establishment, Manufacturer, Repacker / relabeler, Specification developer

Other names on FDA records

Candulor AG · DSSM AG · Ivoclar Vivadent Manufacturing Inc. · Candulor Dental GmbH

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8010208). 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.