IVOCLAR VIVADENT AG

FDA Device Registration & Listing · SCHAAN, LI · Registration 9612352

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
9612352
FEI Number
3002808636
Entity Name
IVOCLAR VIVADENT AG
City/State/Country
SCHAAN, LI
Establishment Address
BENDERERSTRASSE 2, SCHAAN FL-9494, LI
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
IVOCLAR VIVADENT (Owner Number: 8010208)
Owner / Operator Contact Address
175 Pineview Dr., Amherst, NY 14228, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K110756
PMA Number
N/A

All Registered Proprietary Names

OptraGloss Politip Telio CAD Abutment Solutions- extra systems Helioseal F Plus SR Ivocap High Impact IPS e.max CAD Abutment Solutions- extra systems Ivotion Bond Ivotion Base Ivotion SR Vivodent S PE SR Orthotyp S PE SR Vivodent S DCL SR Orthotyp S DCL SR Ortholingual S DCL PhysioSelect TCR BonSelect TCR Ivotion Dent Ivotion Base Print SR Modelling Liquid SR Nexco Retention Flow Stains for Resin Teeth finisher SR Nexco SR Nexco Stains SR Nexco Paste SR Nexco Liner SR Nexco Opaquer SR Link Bluephase PowerCure IvoBase Hybrid IvoBase High Impact Excite F DSC Excite F Monobond Etch & Prime Cervitec F Telio Link IPS Empress CAD for Planmill IPS Empress CAD for PrograMill IPS Empress CAD for M-Center IPS EmpressCAD Syntac SR Orthotyp Candulor brands SR Vivodent Preference Posterior SR Ivostar Preference Anterior SR Gnathostar SR Vivodent A-D SR Orthotyp A-D PhysioStar NFC Plus Bonartic II NFC Plus Condyloform II NFC Plus IPS e.max CAD Crystall SR Orthotyp S SR Ortholingual S Tetric 100 Bulk Flow Tetric PowerFlow IPS Empress Direct Tetric PowerFill Tetric 100 Bulk Fill Variolink Esthetic LC Variolink Esthetic DC Variolink 100 Virtual Dispenser Dispenser ZirCAD Cement Mixing Tips VivaPen Snap On Cannulas Vivadent Applicator Virtual Tips Variolink Application Tips Multilink Applicator Root Canal Tips Mixing Cannulas Intraoral Tips Mixing Tips AccuDent XD Impression Tray Centric Tray AccuDent XD Tray Adhesive PREFERENCE Helioseal Clear Tetric 100 Universal IPS Ivocolor IPS Ivocolor Intro Kit IPS e.max Ceram Art Adhese Universal Adhese 100 Adhese Universal kit VivaPen Adhese Universal Refill VivaPen Adhese Universal Test Pack VivaPen Fluor Protector S Silamat S6 TelioCAD for M-Center TelioCAD for Milling Center Telio CAD for PlanMill Telio CAD for Cerec Telio CAD LT discs Telio CAD disc Telio CAD SR Vivoperl Bonartic CT Physioset CT IPS e.max CAD Abutment Solutions IPS e.max CAD CER/inLab LT Telio CAD Abutment Solutions Telio CAD A16 Abutment Solutions for CEREC/InLab Starter Kit Heliomolar Trans Shades OptraDam Plus IPS e.max Press MT IPS e.max Press IPS e.max Press Multi IPS e.max ZirCAD Prime Adhese 2 OptraGate Small Assortment Blue & Pink OptraGate Junior Assortment Blue & Pink OptraGate for Scanning Assortment OptraGate Regular OptraGate Test Pack OptraGate Assortment OptraGate Small OptraGate Junior OptraGate 2 IPS Style Ceram IPS Style Ceram One IPS Build-Up Liquid IPS Style Ceram Transpa Articulator CA 3 STRATOS Monobond Plus Multilink Hybrid Abutment Test Pack SR-IVOLEN TRAY MATERIAL SR-IVOLEN ProArt CAD Try-In Telio Onlay Telio Inlay Cavifil Injector OptraSculpt Instruments OptraStick Proxyt VD Polishing Paste IPS e.max CAD for Planmill IPS e.max CAD MT IPS e.max CAD LT IPS e.max ZirCAD for Inlab IPS e.max CAD Impulse IPS e.max CAD HT IPS e.max CAD for InLab IPS e.max ZirCAD for PlanMill IPS e.max CAD CEREC IPS e.max CAD IPS e.max ZirCAD CAD/CAM CEREC Starter Kit CAD/CAM PlanMill Starter Kit Heliobond IPS e.max Zirconia OptraGate Dry Control Gnathometer- CAD Gnathometer-M Tetric EvoFlow Tetric 100 Flow Tetric 100 Flow 2 ProArt CAD Splint SR Ivocron OptraSculpt OptraSculpt Pad VivaPen Sleeves Bluephase G2 Sleeves Bluephase Style Sleeves Bluephase G4 Sleeves Barrier Sleeves IPS e.max Ceram Selection IPS e.max Ceram IPS Empress Staining IPS e.max Ceram Power IPS e.max CAD Crystall Glaze Spray IPS e.max CAD Crystall Stains IPS e.max CAD Crystall Shades IPS e.max CAD Crystall Glaze Paste IPS e.max Ceram Intro Kit IPS e.max Ceram Glaze Spray IPS e.max Press IPS e.max Press LT IPS e.max CAD Cryst Glaze Paste Fluo IPS e.max Press HO IPS e.max Press HT Heliomolar Heliomolar Flow SR Ivocap Tetric Evo-Line System Kit Tetric Evo-Line Tetric Prime Tetric Evo-Line Workshop Kit Tetric EvoCeram Tetric 100 Universal 2 Tetric Line Adhese Universal DC Cention Primer Bluephase G4 Bluephase G4 100 Bluephase EasyCure

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EIH Powder, Porcelain Dental Class 2 872.6660 2018-06-14
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-15
EHJ Disk, Abrasive Dental Class 1 872.6010 2001-10-25
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-11-30
PNP Dental Abutment Design Software For Dental Laboratory Dental Class 2 872.3630 2020-11-30
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2019-07-30
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-28
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2007-11-14
PNP Dental Abutment Design Software For Dental Laboratory Dental Class 2 872.3630 2019-09-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-09-09
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2015-08-13
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2016-05-19
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2024-03-06
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2013-01-29
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-29
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2007-11-29
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2019-07-09
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2012-05-24
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2010-03-11
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2015-04-09
LBH Varnish, Cavity Dental Class 2 872.3260 2020-02-12
EMA Cement, Dental Dental Class 2 872.3275 2007-11-14
EIH Powder, Porcelain Dental Class 2 872.6660 2007-11-14
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2007-11-20
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2007-11-15
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2012-05-22
EIH Powder, Porcelain Dental Class 2 872.6660 2011-04-27
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2014-01-28
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2015-06-16
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2009-04-30
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2019-03-14
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2014-11-25
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 2005-07-05
EHY Tray, Impression, Preformed Dental Class 1 872.6880 1990-04-16
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2010-01-29
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2007-11-14
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-14
EIH Powder, Porcelain Dental Class 2 872.6660 2015-10-29
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2014-02-12
LBH Varnish, Cavity Dental Class 2 872.3260 2014-02-12
LBH Varnish, Cavity Dental Class 2 872.3260 2014-10-24
EFD Amalgamator, Dental, Ac-Powered Dental Class 1 872.3100 2004-01-15
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2010-03-16
ELL Teeth, Porcelain Dental Class 2 872.3920 2007-11-14
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-11-05
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2015-09-22
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-14
EIE Dam, Rubber Dental Class 1 872.6300 2001-11-13
EIH Powder, Porcelain Dental Class 2 872.6660 2012-06-28
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2013-01-08
EIH Powder, Porcelain Dental Class 2 872.6660 2015-01-07
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2026-03-16
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 2015-10-29
EIH Powder, Porcelain Dental Class 2 872.6660 2016-05-24
EJP Articulators Dental Class 1 872.3150 2005-07-07
EIH Powder, Porcelain Dental Class 2 872.6660 2021-08-23
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2009-05-13
EMA Cement, Dental Dental Class 2 872.3275 2013-08-22
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 2005-07-07
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2013-03-13
DZN Instruments, Dental Hand Dental Class 1 872.4565 2001-10-25
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2001-10-25
NTK Caries Detector, Laser Light, Transmission Dental Class 2 872.1745 2023-09-20
EIH Powder, Porcelain Dental Class 2 872.6660 2007-11-14
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2007-11-15
EIH Powder, Porcelain Dental Class 2 872.6660 2026-03-16
DYN Mouthpiece, Saliva Ejector Dental Class 1 872.6640 2025-09-16
KZO Ink, Arch Tracing Dental Class 1 872.3150 2017-09-28
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-15
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2003-06-26
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2007-11-14
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-14
KXR Applicator, Resin Dental Class 1 872.3140 2012-01-13
PEM Dental Barriers And Sleeves General, Plastic Surgery Class 2 878.4370 2019-11-07
EIH Powder, Porcelain Dental Class 2 872.6660 2007-11-14
EIH Powder, Porcelain Dental Class 2 872.6660 2007-11-15
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-14
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2007-11-14
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 1982-02-10
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2022-06-07
LBH Varnish, Cavity Dental Class 2 872.3260 2022-06-07
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2011-09-02

Official Correspondent

Dana Glina

US Agent Details

Anderjeet Gulati Business: Ivoclar Vivadent Email: anderjeet.gulati@ivoclar.com Phone: (716) 2642046

Related Public Records

Same Entity

IVOCLAR VIVADENT
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3034244245 DSSM AG Schaan, LI
3011511773 Candulor Dental GmbH Rielasingen-Worblingen Baden-Wurttemberg, DE
3024046877 DSSM GmbH Lindau Bavaria, DE
3004362235 IVOCLAR VIVADENT, INC. Diezmo, Cabuyao City Laguna, PH
1316092 IVOCLAR VIVADENT, INC. AMHERST, NY, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K143656 H.C. Starck Ceramics GmbH StarCeram® Z-Nature, StarCeram® Z-Smile 2015-07-09
K952662 Jeneric/Pentron, Inc. COMP=FLOW 1995-08-28
K171147 Bisco, Inc. REVEAL Bulk 2017-08-04
K770922 Espe GmbH (Us) DENTAL RESTORATIVE IN CAPSULES 1977-06-01
K153476 Kuraray Noritake Dental, Inc. KATANA AVENCIA Block 2016-08-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0017-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612352. Last updated year: 2026. Please use registration number 9612352 when referencing this establishment in official correspondence.
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