BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GC Initial Brush

    Reg #: 1410097 · FEI: 1410097 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    2
    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
    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

    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

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device