BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Adhese Universal

    Reg #: 3004966444 · FEI: 3004966444 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Ivoclar Vivadent GmbH
    Registration Number
    3004966444
    FEI Number
    3004966444
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Dr. Adolf-Schneider-Str.4
    City
    Ellwangen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K133318

    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
    Varnish, Cavity LBH

    Proprietary Names

    Adhese Universal Adhese 100 Adhese Universal Test Pack VivaPen Adhese Universal kit VivaPen Adhese Universal Refill VivaPen

    Establishment Types

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