BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    GC Dental Mexicana, S.A. de C.V.

    Reg #: 3027241817 · FEI: 3027241817 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    28
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GC Dental Mexicana, S.A. de C.V.
    Registration Number
    3027241817
    FEI Number
    3027241817
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    22a Avenida No. 233, Cumbres
    City
    Monterrey Nuevo Leon
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K091106

    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, Tooth Shade, Resin EBF
    Adhesive, Bracket And Tooth Conditioner, Resin DYH

    Proprietary Names

    EQUIA Forte EQUIA Forte Fil EQUIA Forte Coat EQUIA EQUIA Forte HT Fil EQUIA Coat EQUIA Fil GC Gold Label Hybrid FUJI II LC CAPSULE GC Fuji Direct GC Fuji Automix LC Fuji Duet GC Gold Label 1 Luting and Lining FUJI I GC Fuji IX GP FAST GC Fuji IX GP Capsule FUJI IX GP GC FUJICEM BULK FujiCEM(AutoCompatible) GC Fuji Ortho LC GC FUJI IX GP EXTRA GC Fujii Plus No Etch Fuji Plus GC Fuji PLUS GC Fuji PLUS CONDITIONER GC Fuji PLUS CAPSULE MIRACLE MIX CAPSULE FUJI

    Establishment Types

    Repack or Relabel Medical Device