BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Ivoclar Vivadent GmbH

    Reg #: 3004966444 · FEI: 3004966444 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    257
    Establishment Types
    2
    Classifications
    30

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    Registration Details

    Registration Name
    Ivoclar Vivadent GmbH
    Registration Number
    3004966444
    FEI Number
    3004966444
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Dr. Adolf-Schneider-Str.4
    City
    Ellwangen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K124008

    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
    Denture, Plastic, Teeth ELM
    Abutment, Implant, Dental, Endosseous NHA
    Instruments, Dental Hand DZN
    Material, Impression Tray, Resin EBH
    Coating, Filling Material, Resin EBD
    Sealant, Pit And Fissure, And Conditioner EBC
    Material, Tooth Shade, Resin EBF
    Agent, Tooth Bonding, Resin KLE
    Powder, Porcelain EIH
    Varnish, Cavity LBH
    Cement, Dental EMA
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Crown And Bridge, Temporary, Resin EBG
    Dental Abutment Design Software For Dental Laboratory PNP
    Ink, Arch Tracing KZO
    Disk, Abrasive EHJ
    Applicator, Resin KXR
    Activator, Ultraviolet, For Polymerization EBZ
    Amalgamator, Dental, Ac-Powered EFD
    Accessories, Implant, Dental, Endosseous NDP
    Accessories, Retractor, Dental EIF
    Teeth, Porcelain ELL
    Syringe, Restorative And Impression Material EID
    Facebow KCR
    Dam, Rubber EIE
    Alloy, Metal, Base EJH
    Dental Barriers And Sleeves PEM
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Tray, Impression, Preformed EHY
    Articulators EJP

    Proprietary Names

    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 IPS e.max Press Abutment Solutions for Nobel Biocare Cavifil Injector OptraSculpt Instruments OptraStick SR-IVOLEN TRAY MATERIAL SR-IVOLEN ProArt CAD Try-In IPS Empress Direct Effect SR Orthotyp Candulor brands SR Vivodent Preference Posterior SR Ivostar Preference Anterior SR Gnathostar SR Vivodent A-D SR Orthotyp A-D Monobond Etch & Prime IPS e.max ZirCAD MT Multi blocks IPS e.max ZirCAD MT discs IPS e.max ZirCAD Prime Esthetic IPS e.max CAD Crystall IPS Empress Direct Color IPS Empress Direct Opaque Chairside Workflow 3D Printing Adhese Universal Adhese 100 Adhese Universal kit VivaPen Adhese Universal Refill VivaPen Adhese Universal Test Pack VivaPen Tetric CAD Tetric CAD for PlanMill Tetric CAD for PrograMill Starter Kit Tetric CAD for CEREC Starter Kit Heliobond Adhese 2 Helioseal Clear SpeedCem Plus Multilink Speed SpeedCEM 100 Excite F DSC Excite F IPS e.max Press MT IPS e.max Press IPS e.max Press Multi IPS Empress Direct Ivotion Bond Ivotion Base Ivotion SR Link SR Orthotyp S SR Ortholingual S 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 e.max Press LT IPS e.max CAD Cryst Glaze Paste Fluo IPS e.max Press HO IPS e.max Press HT Cervitec F IPS e.max CAD Abutment Solutions- extra systems Multilink Hybrid Abutment Test Pack Tetric EvoFlow Tetric 100 Flow Tetric 100 Flow 2 Gnathometer- CAD Gnathometer-M Tetric PowerFill Tetric 100 Bulk Fill Heliomolar Heliomolar Flow Telio Onlay Telio Inlay OptraGloss Politip Fluor Protector S SR Ivocap High Impact OptraSculpt OptraSculpt Pad Heliomolar Trans Shades Bluephase G4 Bluephase G4 100 Bluephase EasyCure Multilink Automix Multilink Automix Try-In Silamat S6 Monobond Plus 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 Ivotion Base Print IvoBase Hybrid IvoBase High Impact PhysioStar NFC Plus Bonartic II NFC Plus Condyloform II NFC Plus Tetric 100 Bulk Flow Tetric PowerFlow 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 SR Ivocap IPS Ivocolor IPS Ivocolor Intro Kit IPS e.max Ceram Art ProArt CAD Splint 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 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 SR Vivoperl Bonartic CT Physioset CT 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 Telio CAD Abutment Solutions Telio CAD A16 Abutment Solutions for CEREC/InLab Starter Kit Bluephase PowerCure Helioseal F Plus Universal Transferbow System (UTS) CAD Candulor Registration Set CRS-10 Bite Fork Set Bite Fork UNIVERSAL TRANSFERBOW UNIVERSAL TRANSFERBOW SYSTEM (UTS) 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 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 Zirconia IPS Style Ceram IPS Style Ceram One IPS Build-Up Liquid IPS Style Ceram Transpa OptraDam Plus Spartan Solder Spartan Ceramic Solder d.SIGN 30 Colado NC Cervitec Plus IPS InLine IPS Classic IPS InLine System Powder Opaquer IPS InLine One IPS Classic Powder Opaquer VivaPen Sleeves Bluephase G2 Sleeves Bluephase Style Sleeves Bluephase G4 Sleeves Barrier Sleeves IPS Empress CAD for Planmill IPS Empress CAD for PrograMill IPS Empress CAD for M-Center IPS EmpressCAD Telio Link Telio CAD Abutment Solutions- extra systems Variolink Esthetic LC Variolink Esthetic DC Variolink 100 SR ORTHOLINGUAL DCL SR VIVODENT DCL SR Orthotyp DCL Candulor brand denture teeth Candulor Physioset TCR Candulor Bonartic TCR BlueLine SR ORTHOPLANE DCL Syntac IPS e.max ZirCAD Prime Adhese Universal DC Cention Primer Proxyt VD Polishing Paste Multilink Primer A + B SR Ivocron IPS e.max Press Abutment Solutions AccuDent XD Impression Tray Centric Tray AccuDent XD Tray Adhesive Articulator CA 3 STRATOS IPS e.max CAD Abutment Solutions IPS e.max CAD CER/inLab LT Tetric 100 Universal

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device