BEUDAMED
    FDA Registration Inactive 🇲🇽 Mexico

    GC America Inc.

    · Expires 2026
    Products
    3
    Proprietary Names
    17
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    GC America Inc.
    Status
    Inactive
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Carretera Federal 45, Irapuato-Silao KM 144 + 300 Parque Industrial Hybrid Park,, Int 26, 27, 33 Ejido de Vallejos
    City
    Guanajuato Mexico
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K993973

    Owner / Operator

    Firm Name
    GC America Inc.
    Operator Number
    8030268
    Address
    3737 W. 127th Street
    City
    Alsip
    State
    IL
    Postal Code
    60803
    Country
    US

    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, Tooth Shade, Resin EBF
    Cement, Dental EMA
    Varnish, Cavity LBH

    Proprietary Names

    FUJI II LC CAPSULE GC Fuji IX GP FAST GC Fuji IX GP Capsule FUJI IX GP Miracle Mix MI Varnish GC FujiCEM Evolve GC FujiCEM 2 (Improved) GC Fuji Triage EP EQUIA Forte EQUIA Forte Fil EQUIA Forte Coat EQUIA EQUIA Forte HT Fil EQUIA Coat EQUIA Fil GC Gold Label Hybrid

    Establishment Types

    Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device