BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    GC CORPORATION-FUJI OYAMA FACTORY

    Reg #: 3002807050 · FEI: 3002807050 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    88
    Establishment Types
    3
    Classifications
    14

    Registration Details

    Registration Name
    GC CORPORATION-FUJI OYAMA FACTORY
    Registration Number
    3002807050
    FEI Number
    3002807050
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    584-1 NAKAHINATA OYAMA-CHO
    City
    SUNTO-GUN, Shizuoka-Ken
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K070319

    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 9263261

    Products

    Device Name Product Code
    Cement, Dental EMA
    Material, Impression ELW
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Material, Tooth Shade, Resin EBF
    Agent, Tooth Bonding, Resin KLE
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Powder, Porcelain EIH
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE
    Liner, Cavity, Calcium Hydroxide EJK
    Varnish, Cavity LBH
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Coating, Filling Material, Resin EBD
    Activator, Ultraviolet, For Polymerization EBZ

    Proprietary Names

    GC FUJI IX GP EXTRA Freegenol Fuji Filling LC Fuji Filling LC Self Conditioner GC Fuji Filling LC GC Fuji Filling LC Self Conditioner AIM2 GC Fuji Ortho LC Gradia Direct Loflo Miracle Mix GC Fuji Direct GC Fuji Automix LC Fuji Duet Cavity Conditioner Fuji Triage GC Fuji Triage FUJI II LC CAPSULE G-Bond GC Gold Label 1 Luting and Lining FUJI I GC FUJI COAT LC MI PASTE Initial LiSi Press GC Lisi Press Vest Fujivest II GC FujiVest FUJI BOND LC JNE Implant System GC FUJICEM BULK FujiCEM(AutoCompatible) 76 EMA LINING CEMENT GC Lining Cement Fuji Varnish Fuji IX Fuji IX ART GC Gold Label 9 HS Post. Rest. FUJI LINING CEMENT LIGHT CURE Fuji Ortho LC ORTHO CONDITIONER GC Fuji ORTHO LC MI Varnish GC Fuji IX GP FAST GC Fuji IX GP Capsule FUJI IX GP EQUIA Forte EQUIA Forte Fil EQUIA Forte Coat EQUIA EQUIA Forte HT Fil EQUIA Coat EQUIA Fil GC Gold Label Hybrid G-CEM Automix GC GAM-100 GC Reline II GC Pas/Cion Aroma Fine Plus Aroma Fine MIRACLE MIX CAPSULE GC Optiglaze G-Coat Plus G-COAT JC-50 GC OPA-100 GC Gel Conditioner GC Fuji Ortho LC Paste Pak Automix ORTHO GEL CONDITIONER Initial LiSi Block GC Fujii Plus No Etch Fuji Plus GC Fuji PLUS GC Fuji PLUS CONDITIONER GC Fuji PLUS CAPSULE 76 ELW BITE CHECKER SILICONE GC Fuji ORTHO BAND PASTE PAK Gradia Direct Flo G-LIGHT GC FUJI ORTHO GC FUJI ORTHO SC G-Cem G-CEM CAPSULE FUJI II LC (IMPROVED) GC FUJI TEMP FUJI II LC Fuji Lining LC Paste Pak GC Fuji Lining LC Paste Pak GVC-100 FUJI

    Establishment Types

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