BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Elite HD+ Monophase

    Reg #: 9614794 · FEI: 3003762341 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ZHERMACK S.P.A.
    Registration Number
    9614794
    FEI Number
    3003762341
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA BOVAZECCHINO, 100
    City
    BADIA POLESINE (RO) Rovigo
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K022653

    Owner / Operator

    Firm Name
    DENTSPLY SIRONA INC
    Operator Number
    2511302
    Address
    221 WEST PHILADELPHIA ST., SUITE 60W
    City
    York
    State
    PA
    Postal Code
    17401
    Country
    US

    US Agent

    Business Name
    DENTSPLY SIRONA INC
    Contact Name
    Dan Eagar
    Address
    13320 Ballantyne Corp Pl
    City
    Charlotte
    State
    NC
    ZIP
    28277
    Country
    US
    Email
    [email protected]
    Phone
    704 4926977

    Products

    Device Name Product Code
    Material, Impression ELW

    Proprietary Names

    Elite HD+ Monophase Elite HD+ Maxi Tray Material Elite HD+ Tray Material

    Establishment Types

    Manufacture Medical Device