BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    GC Lining Cement

    Reg #: 3002807050 · FEI: 3002807050 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GC CORPORATION-FUJI OYAMA FACTORY
    Registration Number
    3002807050
    FEI Number
    3002807050
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    584-1 NAKAHINATA OYAMA-CHO
    City
    SUNTO-GUN, Shizuoka-Ken
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K851468

    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 9263261

    Products

    Device Name Product Code
    Cement, Dental EMA

    Proprietary Names

    GC Lining Cement 76 EMA LINING CEMENT

    Establishment Types

    Repack or Relabel Medical Device