BEUDAMED
    FDA Registration Active 🇱🇮 Liechtenstein

    IVOCLAR VIVADENT AG

    Reg #: 9612352 · FEI: 3002808636 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    259
    Establishment Types
    5
    Classifications
    32

    Registration Details

    Registration Name
    IVOCLAR VIVADENT AG
    Registration Number
    9612352
    FEI Number
    3002808636
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    BENDERERSTRASSE 2
    City
    SCHAAN
    Country
    LI

    Regulatory Submissions

    510(k) Number
    K130991

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

    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 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 IPS e.max Press Abutment Solutions IPS e.max Press Abutment Solutions for Nobel Biocare Spartan Solder Spartan Ceramic Solder d.SIGN 30 Colado NC SR ORTHOLINGUAL DCL SR VIVODENT DCL SR Orthotyp DCL Candulor brand denture teeth Candulor Physioset TCR Candulor Bonartic TCR BlueLine SR ORTHOPLANE DCL IPS InLine IPS Classic IPS InLine System Powder Opaquer IPS InLine One IPS Classic Powder Opaquer IPS Empress Direct Effect Cervitec Plus IPS e.max ZirCAD MT Multi blocks IPS e.max ZirCAD MT discs IPS e.max ZirCAD Prime Esthetic Multilink Primer A + B IPS Empress Direct Color IPS Empress Direct Opaque Chairside Workflow 3D Printing Tetric CAD Tetric CAD for PlanMill Tetric CAD for PrograMill Starter Kit Tetric CAD for CEREC Starter Kit 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 Multilink Automix Multilink Automix Try-In Universal Transferbow System (UTS) CAD Candulor Registration Set CRS-10 Bite Fork Set Bite Fork UNIVERSAL TRANSFERBOW UNIVERSAL TRANSFERBOW SYSTEM (UTS) SpeedCem Plus Multilink Speed SpeedCEM 100

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198