BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ivoclar Vivadent Manufacturing, Inc

    Reg #: 2244842 · FEI: 2244842 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    103
    Establishment Types
    2
    Classifications
    12

    Registration Details

    Registration Name
    Ivoclar Vivadent Manufacturing, Inc
    Registration Number
    2244842
    FEI Number
    2244842
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    500 MEMORIAL DR.
    City
    Somerset
    State
    NJ
    ZIP
    08873
    Country
    US

    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

    Products

    Device Name Product Code
    Powder, Porcelain EIH
    Agent, Tooth Bonding, Resin KLE
    Varnish, Cavity LBH
    Wax, Dental, Intraoral EGD
    Material, Tooth Shade, Resin EBF
    Tray, Impression, Preformed EHY
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Crown And Bridge, Temporary, Resin EBG
    Cement, Dental EMA
    Sealant, Pit And Fissure, And Conditioner EBC
    Denture, Plastic, Teeth ELM
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    IPS Ivocolor IPS Ivocolor Intro Kit IPS e.max Ceram Art Monobond Plus Adhese Universal Adhese 100 Adhese Universal kit VivaPen Adhese Universal Refill VivaPen Adhese Universal Test Pack VivaPen Aesthetic Wax Multilink Automix Multilink Automix Try-In 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 IPS e.max ZirCAD Prime Tetric 100 Universal Cervitec Plus 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 IPS e.max Press MT IPS e.max Press Multi AccuDent XD Impression Tray Centric Tray AccuDent XD Tray Adhesive IPS Empress CAD for Planmill IPS Empress CAD for PrograMill IPS Empress CAD for M-Center IPS EmpressCAD Tetric Evo-Line System Kit Tetric Evo-Line Tetric Prime Tetric Evo-Line Workshop Kit Tetric EvoCeram Tetric 100 Universal 2 Tetric Line Ivotion Bond Ivotion Base Ivotion Tetric EvoFlow Tetric 100 Flow Tetric 100 Flow 2 Telio Onlay Telio Inlay Heliobond Tetric 100 Bulk Flow Tetric PowerFlow Tetric PowerFill Tetric 100 Bulk Fill IPS e.max ZirCAD MT Multi blocks IPS e.max ZirCAD MT discs IPS e.max ZirCAD Prime Esthetic Multilink Hybrid Abutment Test Pack IPS Empress Direct Helioseal F Plus Cervitec F IPS e.max CAD Crystall IPS Style Ceram IPS Style Ceram One IPS Build-Up Liquid IPS Style Ceram Transpa 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 Zirconia Variolink Esthetic LC Variolink Esthetic DC Variolink 100 IPS InLine IPS Classic IPS InLine System Powder Opaquer IPS InLine One IPS Classic Powder Opaquer 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 CAD Abutment Solutions IPS e.max CAD CER/inLab LT

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device