BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    GC EUROPE N.V.

    Reg #: 3003775534 · FEI: 3003775534 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    41
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    GC EUROPE N.V.
    Registration Number
    3003775534
    FEI Number
    3003775534
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Researchpark Haasrode - Leuven 1240, Interleuvenlaan 33
    City
    LEUVEN Vlaams Brabant
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K946100

    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
    Cement, Dental EMA
    Material, Impression ELW
    Powder, Porcelain EIH
    Crown And Bridge, Temporary, Resin EBG
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF

    Proprietary Names

    GC Fujii Plus No Etch Fuji Plus GC Fuji PLUS GC Fuji PLUS CONDITIONER GC Fuji PLUS CAPSULE GC FujiCEM Evolve GC FujiCEM 2 (Improved) Exajet Initial Lustre Pastes NF Initial IQ Initial LiSi Initial PC Initial Initial TI Initial Spectrum Stains Initial Lustre Paste One Initial IQ SQIN Creation Creation CC Creation Magic Colour Creation ZI-CT, ZI-F Lisi PressVest Creation LS Initial One Initial Brush GC Temp PRINT GC Initial Zirconia Disk ST GC Initial Zirconia Disk HT GC Aadva Zr Disk GC Initial ZR Disk ML Elite GC Gold Label 1 Luting and Lining FUJI I Coe Cal FujiRock GC Aadva Scanner GC Aadva IOS LD-1 Milling Machiine GC Aadva IOS 200 GC Aadva IOS 100P Aadva Lab Scanner 3 Aadva Lab Scanner 2

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device