BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    G-Fix

    Reg #: 9613953 · FEI: 3002807052 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GC DENTAL PRODUCTS CORP.
    Registration Number
    9613953
    FEI Number
    3002807052
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2-285 TORIIMATSU-CHO
    City
    KASUGAI-SHI Aichi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K151541

    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

    US Agent

    Business Name
    GC America Inc.
    Contact Name
    Futoshi Fusejima
    Address
    3737 W 127th St
    City
    Alsip
    State
    IL
    ZIP
    60803
    Country
    US
    Email
    [email protected]
    Phone
    708 5970900 ext. 4042

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF

    Proprietary Names

    G-Fix GC Ortho Connect Flow

    Establishment Types

    Manufacture Medical Device