IVOCLAR VIVADENT, INC.

FDA Device Registration & Listing · Mississauga Ontario, CA · Registration 3009496224

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
3009496224
FEI Number
3009496224
Entity Name
IVOCLAR VIVADENT, INC.
City/State/Country
Mississauga Ontario, CA
Establishment Address
1-6600 Dixie Road, Mississauga Ontario L5T 2Y, CA
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
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
K040951
PMA Number
N/A

All Registered Proprietary Names

Excite F DSC Excite F IPS e.max Press Abutment Solutions Ivotion Bond Ivotion Base Ivotion Ivotion Base Print AccuDent XD Impression Tray Centric Tray AccuDent XD Tray Adhesive Articulator CA 3 STRATOS SR Ivocap High Impact Telio CAD Abutment Solutions Telio CAD A16 Abutment Solutions for CEREC/InLab Starter Kit VivaPen Sleeves Bluephase G2 Sleeves Bluephase Style Sleeves Bluephase G4 Sleeves Barrier Sleeves 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 Tetric 100 Universal Rim Former New Bite Gauge Bite Plane 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 Telio Onlay Telio Inlay Spartan Solder Spartan Ceramic Solder d.SIGN 30 Colado NC Universal Transferbow System (UTS) CAD Candulor Registration Set CRS-10 Bite Fork Set Bite Fork UNIVERSAL TRANSFERBOW UNIVERSAL TRANSFERBOW SYSTEM (UTS) Capricorn 15 Universal Solder 1015 W Super Solder Ceramic Solder Elektra Evolution Lite Solarcast 20 W-3 d.SIGN 91 Laser C&B White d.SIGN 53 IS-64 Aquarius Magenta d.SIGN 59 Laser C&B Yellow Aquarius Ceramic Solder Special High Fusing White Ceramic Solder Harmony X-Hard d.SIGN 67 W-2 Lodestar Universal Solder PKF Harmony 2 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 ZirCAD Cement Cavifil Injector OptraSculpt Instruments OptraStick 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 IPS Empress Direct Effect Helioseal Clear SR Vivoperl Bonartic CT Physioset CT Cervitec Plus OptraDam Plus Bluephase G4 Bluephase G4 100 Bluephase EasyCure Monobond Plus IPS e.max CAD Abutment Solutions- extra systems SR Orthotyp S SR Ortholingual S Multilink Automix Multilink Automix Try-In Proxyt VD Polishing Paste Valiant PhD IPS Empress CAD for Planmill IPS Empress CAD for PrograMill IPS Empress CAD for M-Center IPS EmpressCAD Multilink Hybrid Abutment Test Pack SR Ivocron IPS Empress Direct SpeedCem Plus Multilink Speed SpeedCEM 100 IPS e.max Zirconia 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 Tetric CAD Tetric CAD for PlanMill Tetric CAD for PrograMill Starter Kit Tetric CAD for CEREC Starter Kit Heliobond Syntac Heliomolar Heliomolar Flow Monobond Etch & Prime Gnathometer- CAD Gnathometer-M Valiant Valiant Sure-Cap IPS e.max ZirCAD Prime Tetric PowerFill Tetric 100 Bulk Fill ProArt CAD Splint OptraSculpt OptraSculpt Pad IPS e.max CAD Crystall OptraGloss Politip Cervitec F 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 BasePlast Fibers AutoPlast Monomer BasePlast Monomer BasePlast Polymer Aesthetic Intensiv Color AutoPlast AutoPlast Polymer Triplex Cold Triplex Hot Aesthetic Cold Probase High Impact Hot XPLEX Probase Hot Probase Cold Aesthetic Hot Probase High Impact Cold SR ORTHOLINGUAL DCL SR VIVODENT DCL SR Orthotyp DCL Candulor brand denture teeth Candulor Physioset TCR Candulor Bonartic TCR BlueLine SR ORTHOPLANE DCL Adhese 2 IPS e.max Press MT IPS e.max Press IPS e.max Press Multi IPS InLine IPS Classic IPS InLine System Powder Opaquer IPS InLine One IPS Classic Powder Opaquer 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 Tetric EvoFlow Tetric 100 Flow Tetric 100 Flow 2 SR Ivocap Fluor Protector S IvoBase Hybrid IvoBase High Impact IPS e.max Press Abutment Solutions for Nobel Biocare Tetric Evo-Line System Kit Tetric Evo-Line Tetric Prime Tetric Evo-Line Workshop Kit Tetric EvoCeram Tetric 100 Universal 2 Tetric Line IPS e.max ZirCAD MT Multi blocks IPS e.max ZirCAD MT discs IPS e.max ZirCAD Prime Esthetic Helioseal F Plus Bluephase PowerCure Adhese Universal Adhese 100 Adhese Universal kit VivaPen Adhese Universal Refill VivaPen Adhese Universal Test Pack VivaPen IPS Style Ceram IPS Style Ceram One IPS Build-Up Liquid IPS Style Ceram Transpa Heliomolar Trans Shades SR Link

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2010-03-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2012-11-02
EIH Powder, Porcelain Dental Class 2 872.6660 2012-11-02
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2015-08-13
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2024-03-06
EHY Tray, Impression, Preformed Dental Class 1 872.6880 1990-04-16
EJP Articulators Dental Class 1 872.3150 2005-07-07
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2007-11-14
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2015-09-22
PEM Dental Barriers And Sleeves General, Plastic Surgery Class 2 878.4370 2019-11-07
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2007-11-15
ELW Material, Impression Dental Class 2 872.3660 2021-03-26
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2012-05-22
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-15
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-14
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 2019-02-25
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2013-01-29
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2013-03-13
EJH Alloy, Metal, Base Dental Class 2 872.3710 2006-10-20
KCR Facebow Dental Class 1 872.3220 2005-07-07
EJS Alloy, Other Noble Metal Dental Class 2 872.3060 2001-10-25
EIH Powder, Porcelain Dental Class 2 872.6660 2007-11-14
EMA Cement, Dental Dental Class 2 872.3275 2021-03-03
DZN Instruments, Dental Hand Dental Class 1 872.4565 2001-10-25
NTK Caries Detector, Laser Light, Transmission Dental Class 2 872.1745 2023-09-20
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2010-03-16
EBD Coating, Filling Material, Resin Dental Class 2 872.3310 2015-10-29
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2015-10-29
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2015-10-29
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2007-11-14
ELL Teeth, Porcelain Dental Class 2 872.3920 2007-11-14
LBH Varnish, Cavity Dental Class 2 872.3260 2007-11-14
EIE Dam, Rubber Dental Class 1 872.6300 2001-11-13
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2011-09-02
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2009-05-13
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
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2014-01-28
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2013-03-13
EIH Powder, Porcelain Dental Class 2 872.6660 2021-08-23
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2001-10-25
EJJ Alloy, Amalgam Dental Class 2 872.3070 2007-11-14
EIH Powder, Porcelain Dental Class 2 872.6660 2007-11-14
EMA Cement, Dental Dental Class 2 872.3275 2013-08-22
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
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2009-04-30
EMA Cement, Dental Dental Class 2 872.3275 2009-06-04
EIH Powder, Porcelain Dental Class 2 872.6660 2026-03-16
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 2015-10-29
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2018-06-08
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2007-11-15
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2007-11-20
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-14
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2015-04-09
KZO Ink, Arch Tracing Dental Class 1 872.3150 2017-09-28
EJJ Alloy, Amalgam Dental Class 2 872.3070 2007-11-14
EIH Powder, Porcelain Dental Class 2 872.6660 2015-01-07
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2019-03-14
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2003-06-26
KXR Applicator, Resin Dental Class 1 872.3140 2012-01-13
EIH Powder, Porcelain Dental Class 2 872.6660 2011-04-27
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2013-01-08
EHJ Disk, Abrasive Dental Class 1 872.6010 2001-10-25
LBH Varnish, Cavity Dental Class 2 872.3260 2020-02-12
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 2005-07-05
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2004-10-06
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-28
ELM Denture, Plastic, Teeth Dental Class 2 872.3590 2004-01-14
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2026-03-16
EIH Powder, Porcelain Dental Class 2 872.6660 2012-06-28
EIH Powder, Porcelain Dental Class 2 872.6660 2007-11-14
EIH Powder, Porcelain Dental Class 2 872.6660 2007-11-14
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-15
ELW Material, Impression Dental Class 2 872.3660 2007-11-28
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2007-11-14
LBH Varnish, Cavity Dental Class 2 872.3260 2014-10-24
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2012-05-24
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2013-04-09
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 1982-02-10
EIH Powder, Porcelain Dental Class 2 872.6660 2015-12-17
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2019-07-30
ELW Material, Impression Dental Class 2 872.3660 2013-01-04
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2019-07-09
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2014-02-12
LBH Varnish, Cavity Dental Class 2 872.3260 2014-02-12
EIH Powder, Porcelain Dental Class 2 872.6660 2016-05-24
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-11-14
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

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
K020499 Jeneric/Pentron, Inc. BOND-3 ADHESIVE 2002-04-22
K801093 Dentsply Intl. PRISMA-BOND 1980-05-20
K061981 Apex Dental Materials, Inc. SURPASS 2006-07-31
K110302 3M Espe AG ADHESIVE EXL-759 2011-05-19
K071131 3M Espe AG Dental Products UNO 2007-07-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009496224. Last updated year: 2026. Please use registration number 3009496224 when referencing this establishment in official correspondence.
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