BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    IVOCLAR VIVADENT, INC.

    Reg #: 3009496224 · FEI: 3009496224 · Expires 2026
    View on FDA
    Products
    37
    Proprietary Names
    327
    Establishment Types
    1
    Classifications
    37

    Registration Details

    Registration Name
    IVOCLAR VIVADENT, INC.
    Registration Number
    3009496224
    FEI Number
    3009496224
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1-6600 Dixie Road
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K093744

    Owner / Operator

    Firm Name
    IVOCLAR VIVADENT
    Operator Number
    8010208
    Address
    175 Pineview Dr.
    City
    Amherst
    State
    NY
    Postal Code
    14228
    Country
    US
    Correspondent
    Dana Glina

    US Agent

    Business Name
    Ivoclar Vivadent
    Contact Name
    Anderjeet Gulati
    Address
    175 Pineview Dr.
    City
    Amherst
    State
    NY
    ZIP
    14228
    Country
    US
    Email
    [email protected]
    Phone
    716 2642046

    Products

    Device Name Product Code
    Agent, Tooth Bonding, Resin KLE
    Abutment, Implant, Dental, Endosseous NHA
    Powder, Porcelain EIH
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Tray, Impression, Preformed EHY
    Articulators EJP
    Dental Barriers And Sleeves PEM
    Denture, Plastic, Teeth ELM
    Material, Impression ELW
    Material, Tooth Shade, Resin EBF
    Gauge, Depth, Instrument, Dental EIL
    Crown And Bridge, Temporary, Resin EBG
    Alloy, Metal, Base EJH
    Facebow KCR
    Alloy, Other Noble Metal EJS
    Cement, Dental EMA
    Instruments, Dental Hand DZN
    Caries Detector, Laser Light, Transmission NTK
    Coating, Filling Material, Resin EBD
    Sealant, Pit And Fissure, And Conditioner EBC
    Teeth, Porcelain ELL
    Varnish, Cavity LBH
    Dam, Rubber EIE
    Activator, Ultraviolet, For Polymerization EBZ
    Dental Abutment Design Software For Dental Laboratory PNP
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Alloy, Amalgam EJJ
    Accessories, Retractor, Dental EIF
    Ink, Arch Tracing KZO
    Accessories, Implant, Dental, Endosseous NDP
    Applicator, Resin KXR
    Disk, Abrasive EHJ
    Syringe, Restorative And Impression Material EID
    Material, Impression Tray, Resin EBH
    Wax, Dental, Intraoral EGD
    Alloy, Gold-Based Noble Metal EJT
    Amalgamator, Dental, Ac-Powered EFD

    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 Physiostar NFC Condyloform II NFC PREFERENCE Multilink Primer A + B IPS Empress Direct Color IPS Empress Direct Opaque Chairside Workflow 3D Printing SR-IVOLEN TRAY MATERIAL SR-IVOLEN ProArt CAD Try-In IPS e.max Press LT IPS e.max CAD Cryst Glaze Paste Fluo IPS e.max Press HO IPS e.max Press HT Aesthetic Wax IPS e.max CAD Abutment Solutions IPS e.max CAD CER/inLab LT Variolink Esthetic LC Variolink Esthetic DC Variolink 100 AccuDent XD Tray Material AccuDent XD Syringe Material Tetric 100 Bulk Flow Tetric PowerFlow 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 XL-X HIgh Fusing Yellow Ceramic Solder Academy Gold XH Callisto Implant 33 Laser Ceramic Yellow Pdf Golden Ceramic Solder Harmony Medium Harmony Hard Brite Gold Maxigold KF Academy Gold Laser Ceramic Yellow Y .585 Fine Gold Solder Low Fusing White Gold Solder W W-1 d.SIGN 98 W-5 d.SIGN 96 HGPKF 1030 Y Solder .615 Fine Gold Solder X-L Y-1 Laser Ceramic White High Fusing White Ceramic Solder Midigold 50 Maxigold Minigold Aquarius Hard Callisto 75 Pd HGPKF 1015 Y Solder Harmony C & B 55 Spartan Plus .650 Fine Gold Solder Callisto CPG IPS Ivocolor IPS Ivocolor Intro Kit IPS e.max Ceram Art Silamat S6 Telio Link Telio CAD Abutment Solutions- extra systems

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device