BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    Z-EVO

    Reg #: 3019741877 · FEI: 3019741877 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ZARC4ENDO
    Registration Number
    3019741877
    FEI Number
    3019741877
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Calle Concejo de Tapia de Casariego, 1- Loc
    City
    GIJON Asturias
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K201993

    Owner / Operator

    Firm Name
    Zarc4Endo S.A.
    Operator Number
    10085865
    Address
    Calle Concejo de Tapia de Casariego, 1- Local
    City
    GIJÓN
    State
    Asturias
    Postal Code
    33204
    Country
    ES
    Correspondent
    MARIA JOSE CALDERON DIEZ

    US Agent

    Business Name
    NuSmile LTD
    Contact Name
    Diane Johnson Krueger
    Address
    3315 W. 12th Street
    City
    Houston
    State
    TX
    ZIP
    77008
    Country
    US
    Email
    [email protected]
    Phone
    713 8610033

    Products

    Device Name Product Code
    Locator, Root Apex LQY
    Handpiece, Direct Drive, Ac-Powered EKX

    Proprietary Names

    Z-EVO Z-APEX Locator Z-EVO Mini

    Establishment Types

    Foreign Private Label Distributor