BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    GC Initial Brush

    Reg #: 9612300 · FEI: 3002808289 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GC CORP.
    Registration Number
    9612300
    FEI Number
    3002808289
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    76-1 HASUNUMA-CHO
    City
    ITABASHI-KU Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K955932

    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 9263050

    Products

    Device Name Product Code
    Material, Impression ELW

    Proprietary Names

    GC Initial Brush GC Cartridge Dispenser II Plunger GC Cartridge Dispenser Intraoral Tips Universal/NDS EXAFLEX IMPRESSION MATERIAL Dispensing Guns Plunger for Universal Dispenser Mixing Tips EXAMIX NDS Universal VPS Adhesive EXAFAST NDS EXAFAST PUTTY EXA Advanced

    Establishment Types

    Manufacture Medical Device