BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AccuDent XD Tray Material

    Reg #: 1316092 · FEI: 1316092 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IVOCLAR VIVADENT, INC.
    Registration Number
    1316092
    FEI Number
    1316092
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    175 PINEVIEW DR.
    City
    AMHERST
    State
    NY
    ZIP
    14228
    Country
    US

    Regulatory Submissions

    510(k) Number
    K143575

    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
    Material, Impression ELW

    Proprietary Names

    AccuDent XD Tray Material AccuDent XD Syringe Material

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility