BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    GC CORP.

    Reg #: 9612300 · FEI: 3002808289 · Expires 2026
    View on FDA
    Products
    23
    Proprietary Names
    165
    Establishment Types
    4
    Classifications
    23

    Registration Details

    Registration Name
    GC CORP.
    Registration Number
    9612300
    FEI Number
    3002808289
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    76-1 HASUNUMA-CHO
    City
    ITABASHI-KU Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K951555

    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
    Powder, Porcelain EIH
    Agent, Tooth Bonding, Resin KLE
    Amalgamator, Dental, Ac-Powered EFD
    Bone Grafting Material, Synthetic LYC
    Material, Impression ELW
    Abutment, Implant, Dental, Endosseous NHA
    Sealant, Pit And Fissure, And Conditioner EBC
    Crown And Bridge, Temporary, Resin EBG
    Varnish, Cavity LBH
    Saliva, Artificial LFD
    Coating, Filling Material, Resin EBD
    Handle, Instrument, Dental EJB
    Implant, Endosseous, Root-Form DZE
    Liner, Cavity, Calcium Hydroxide EJK
    Plaque Disclosing Kit NYH
    Drill, Dental, Intraoral DZA
    Syringe, Restorative And Impression Material EID
    Wax, Dental, Intraoral EGD
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Activator, Ultraviolet, For Polymerization EBZ

    Proprietary Names

    Fuji Varnish Fuji IX Fuji IX ART GC Gold Label 9 HS Post. Rest. EQUIA LC ONE GC Fuji Ortho Band LC Automix GC OPB-100 GC Mixing Tips for Ortho GC Fuji ORTHO BAND LC PASTE PAK G-Cem LinkForce Try-In Paste Multi Primer GC Dual Cure Activator G-Premio Bond DCA G-Multi Primer G-Cem LinkForce G-CEM Try-in Paste G-CEM Veneer Initial LiSi Press GC Lisi Press Vest Fujivest II GC FujiVest GC FUJI COAT LC Gradia Direct Flo Gradia Plus Diapolisher Paste Gradia Diapolisher Paste GC Gradia Diamond Polisher Capsule Mixer CM-II Sympress 120 GC FUJI ORTHO GC FUJI ORTHO SC Cavity Conditioner Fuji Ortho LC ORTHO CONDITIONER GC Fuji ORTHO LC G-aenial Bulk Injectable G-aenial Universal Injectable NMF004A Foundation Initial LiSi Block GC Fujii Plus No Etch Fuji Plus GC Fuji PLUS GC Fuji PLUS CONDITIONER GC Fuji PLUS CAPSULE GC FUJICEM BULK FujiCEM(AutoCompatible) Fit Checker Advanced GC AADVA ABUTMENT GC Aadva Blend GC Fuji IX GP FAST GC Fuji IX GP Capsule FUJI IX GP ExaClear Exabite II NDS FUJI II LC CAPSULE Fuji Filling LC Fuji Filling LC Self Conditioner GC Fuji Filling LC GC Fuji Filling LC Self Conditioner G-aenial Universal Injectable II GC FujiCEM Evolve GC FujiCEM 2 (Improved) FUJI II LC FUJI BOND LC G-CEM ONE Fuji Triage GC Fuji Triage EQUIA Forte EQUIA Forte Fil EQUIA Forte Coat EQUIA EQUIA Forte HT Fil EQUIA Coat EQUIA Fil GC Gold Label Hybrid Fuji Lining LC Paste Pak GC Fuji Lining LC Paste Pak Cerasmart Cerasmart Universal Cerasmart 270 G-aenial Injection Matrix Kit MI Fil G-aenial Universal Flo G-CEM Automix GC GAM-100 GC Dry Mouth Gel GC Oral Moisturizing Gel GC FUJI TEMP GC Optiglaze G-Coat Plus G-COAT APPLIER III Unitip Applier II Applier IV Paste Pak Dispenser Paste Pak Dispenser II GC Fuji Capsule Applier GC Capsule Applier V GC Initial Brush Optiglaze Tips Applicator Holder Microtip Applicator Gradia Brush Tips GC Fuji Ortho LC Elite Cement 100 ISO Functional GC Aadva Implant System FUJI LINING CEMENT LIGHT CURE MI Varnish JNE Implant System GRADIA CORE Coe Ortho Alginate Impreceed Coe Alginate GC Tri Plaque ID Gel Miracle Mix GVC-100 GC Fiber Post Drill Gradia Direct SOLARE SOLARE P Essentia Universal SOLARE BULK G-Bond GC Aadva Abutments Zirconium - BO, AC, BH, SV Cytrans Granules everX Flow GC Pas/Cion Aroma Fine Plus Aroma Fine Impression Syringes Coe Syringe GC Fuji ORTHO BAND PASTE PAK GC Gold Label 1 Luting and Lining FUJI I FIT CHECKER II FUJI II LC (IMPROVED) GC BITE COMPOUND SALIVA CHECK G-Cem G-CEM CAPSULE FUJI II GC Gold Label 2 Univ. Rest MIRACLE MIX CAPSULE GC Fuji Direct GC Fuji Automix LC Fuji Duet AIM2 METALPRIMER II 76 EMA LINING CEMENT GC Lining Cement GC Reline II Unifast Trad GC Plastic Syringe MFP-051 G-aenial Sculpt G-aenial A-Chord Fixpeed Pattern Resin LS GC Fuji Triage EP Gradia Gradia Composite Resin GC Pattern Resin G-LIGHT UniFil Bond

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device