BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Initial One

    Reg #: 1410097 · FEI: 1410097 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GC AMERICA INC.
    Registration Number
    1410097
    FEI Number
    1410097
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3737 W 127th St
    City
    ALSIP
    State
    IL
    ZIP
    60803
    Country
    US

    Regulatory Submissions

    510(k) Number
    K040567

    Owner / Operator

    Firm Name
    GC America Inc.
    Operator Number
    8030268
    Address
    3737 W. 127th Street
    City
    Alsip
    State
    IL
    Postal Code
    60803
    Country
    US
    Correspondent
    Futoshi Fusejima

    Products

    Device Name Product Code
    Powder, Porcelain EIH

    Proprietary Names

    Initial One Initial Initial Lustre Pastes NF Initial IQ Initial LiSi Initial Spectrum Stains Initial PC Initial TI Initial IQ SQIN Initial Lustre Paste One Creation ZI-CT, ZI-F Creation Magic Colour Lisi PressVest Creation Creation CC Creation LS Initial Brush

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198