BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    GC DENTAL PRODUCTS CORP.

    Reg #: 9613953 · FEI: 3002807052 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    122
    Establishment Types
    2
    Classifications
    15

    Registration Details

    Registration Name
    GC DENTAL PRODUCTS CORP.
    Registration Number
    9613953
    FEI Number
    3002807052
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2-285 TORIIMATSU-CHO
    City
    KASUGAI-SHI Aichi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K812406

    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 5970900 ext. 4042

    Products

    Device Name Product Code
    Material, Impression ELW
    Handle, Instrument, Dental EJB
    Cement, Dental EMA
    Coating, Filling Material, Resin EBD
    Sealant, Pit And Fissure, And Conditioner EBC
    Dam, Rubber EIE
    Material, Tooth Shade, Resin EBF
    Agent, Tooth Bonding, Resin KLE
    Saliva, Artificial LFD
    Crown And Bridge, Temporary, Resin EBG
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Powder, Porcelain EIH
    Abutment, Implant, Dental, Endosseous NHA
    Varnish, Cavity LBH

    Proprietary Names

    Exaflex 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 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 Nanocoat Color Optiglaza Color Optiglaze Revotek LC GC Conditioner everX Flow Gradia Gradia Composite Resin G-aenial Bond Unit Dose G-Bond Plus Solare Universal Bond G-aenial Bond G-aenial Bulk Injectable G-aenial Universal Injectable NMF004A GC Dry Mouth Gel GC Oral Moisturizing Gel Unifast III GC Aligner Connect GC Ortho Connect GC Ortho Etching Gel GC Acrylic Primer Gradia Forte G-Cera Orbit LC G-Cera Orbit Color Ceramic Primer II Ceramic Primer Ceramic Primer II Unit Dose METALPRIMER II FIT CHECKER Fixpeed Pattern Resin LS G-Premio Bond GC AADVA BO AC ABUTMENTS GC RELINE SOFT/EXTRA SOFT GC BLUE SILICONE Exa'Lence Fast Fusion Fast Nature-Cryl MC EXA'Lence Exalence 370 GRADIA GUM Freegenol Unifast LC MI Flow Essentia G-aenial Flo MSN-006 TEMPSMART GC-ZIRCONIA Cerasmart Cerasmart Universal Cerasmart 270 Gradia Plus Diapolisher Paste Gradia Diapolisher Paste GC Gradia Diamond Polisher 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 G-Fix GC Ortho Connect Flow G2-Bond Universal BZF-29 G-2 Bond Universal Kit MFP-051 G-aenial Sculpt G-aenial A-Chord GRADIA DIRECT X GC Kalore GDLS-200 G-aenial Injection Matrix Kit MI Fil G-aenial Universal Flo everX Posterior GC KommonBase Gradia Direct SOLARE SOLARE P Essentia Universal SOLARE BULK GC Reline Powder, Liquid GC Reline GC TiON Gingival Protector HTFX-222 G-aenial Flo X Exa'Lence Putty Fusion Putty

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198