GC AMERICA INC.

FDA Device Registration & Listing · ALSIP, IL, US · Registration 1410097

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1410097
FEI Number
1410097
Entity Name
GC AMERICA INC.
City/State/Country
ALSIP, IL, US
Establishment Address
3737 W 127th St, ALSIP, IL 60803, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
GC America Inc. (Owner Number: 8030268)
Owner / Operator Contact Address
3737 W. 127th Street, Alsip, IL 60803, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Nature-Cryl Super HI Impact Nature Cryl HI Plus Unifast LC Gradia Plus Diapolisher Paste Gradia Diapolisher Paste GC Gradia Diamond Polisher Revotek LC GC Dry Mouth Gel GC Oral Moisturizing Gel MSCB-001 Gradia Direct Flo Capsule Mixer CM-II Sympress 120 Ceramic Primer II Ceramic Primer Ceramic Primer II Unit Dose Fuji Filling LC Fuji Filling LC Self Conditioner GC Fuji Filling LC GC Fuji Filling LC Self Conditioner Foundation everX Flow POLISHING STRIPS Ultimate Finishing & Polishing Kit GC Metal Strips EPITEX EPITEX FINISHING HTFX-222 G-aenial Flo X Coe Cide XL G-Premio Bond everStickORTHO Ultimate F&P Kit Initial LiSi Block Coe Tray Plastic GC BITE COMPOUND SALIVA CHECK G-Fix GC Ortho Connect Flow Fuji Lining LC Paste Pak GC Fuji Lining LC Paste Pak GC Aadva Implant System Gradia Direct SOLARE SOLARE P Essentia Universal SOLARE BULK Coe Sideless Impression Tray Regular and Partial Tray Sto-K Tray Spacer Tray Perforated Tray Check Bite Tray McGowan -Winkler Impression Tray Stainless Steel Tray Depressed Anterior Tray Eon Aligner MI Paste Plus GC Tooth Mousse Plus MI Prophy Polish everX Posterior G-aenial Bond Unit Dose G-Bond Plus Solare Universal Bond G-aenial Bond Coe-Rect Kooliner Coe Cal FujiRock GC Aadva Scanner GC Aadva IOS LD-1 Milling Machiine GC Aadva IOS 200 GC Aadva IOS 100P Aadva Lab Scanner 3 Aadva Lab Scanner 2 Exa'Lence Putty Fusion Putty EQUIA Forte EQUIA Forte Fil EQUIA Forte Coat EQUIA EQUIA Forte HT Fil EQUIA Coat EQUIA Fil GC Gold Label Hybrid Foundation 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 Gradia Gradia Composite Resin COE-PAK AUTOMIX NDS Coe-Pak Hard & Fast Set Standard Pak Coe-Pak Standard Pkg GC Initial Zirconia Disk ST GC Initial Zirconia Disk HT GC Aadva Zr Disk GC Initial ZR Disk ML Elite StickSTEPPER StickCARRIER GC Occlusal Matrix Fuji Spatula Dental Prescale II MI PASTE MI Paste GC Tooth Mousse GC FujiCEM Evolve GC FujiCEM 2 (Improved) FIT CHECKER Coe Comfort G-CEM ONE ISO Functional Foundation Exajet GC Fuji ORTHO BAND PASTE PAK Nature-Cryl MC Alike Nogenol Root Canal Sealer GC Pas/Cion Aroma Fine Plus Aroma Fine Unifast III MI Flow Essentia G-aenial Flo GC Fuji Triage EP Coe Soft Coe Lubricant Coe Soft Print everStickPERIO GC TiON Gingival Protector G-Bond Foundation Exa'Lence Fast Fusion Fast GC Reline Powder, Liquid GC Reline MFP-051 G-aenial Sculpt G-aenial A-Chord JC-50 GC OPA-100 GC Gel Conditioner GC Fuji Ortho LC Paste Pak Automix ORTHO GEL CONDITIONER 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 GC Fuji Direct GC Fuji Automix LC Fuji Duet Cytrans Granules FIT CHECKER II GC Reline II MSN-006 TEMPSMART Fuji Ortho LC ORTHO CONDITIONER GC Fuji ORTHO LC Aadva Ti Coloring Service Kooliner Fixpeed Pattern Resin LS Nature Cryl HI-20ET Initial LiSi Press GC Lisi Press Vest Fujivest II GC FujiVest MI Varnish StickNET fibreNet G-Cem G-CEM CAPSULE GC Optiglaze G-Coat Plus G-COAT Unifast Trad G-aenial Injection Matrix Kit MI Fil G-aenial Universal Flo Fuji Varnish Fuji IX Fuji IX ART GC Gold Label 9 HS Post. Rest. Super-Soft Nature-Cryl Pour New Plastone AIM2 everStickC&B G-CEM Automix GC GAM-100 EXAFAST NDS EXAFAST PUTTY Universal VPS Adhesive EXAMIX NDS Intraoral Tips Universal/NDS GC Cartridge Dispenser GC Cartridge Dispenser II Plunger EXAFLEX IMPRESSION MATERIAL Dispensing Guns Plunger for Universal Dispenser Mixing Tips EXA Advanced GC Initial Brush Exa Advance

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2008-01-31
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2008-01-14
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2016-07-13
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2012-11-28
LFD Saliva, Artificial Unknown Class U N/A 2011-01-31
EIH Powder, Porcelain Dental Class 2 872.6660 2016-03-28
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-01-31
EFD Amalgamator, Dental, Ac-Powered Dental Class 1 872.3100 2009-09-16
EMA Cement, Dental Dental Class 2 872.3275 2014-06-03
EMA Cement, Dental Dental Class 2 872.3275 2008-01-31
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2024-01-29
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2019-11-25
EHM Strip, Polishing Agent Dental Class 1 872.6010 2005-04-28
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2014-04-15
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2008-01-14
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2015-04-22
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2013-12-17
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2013-12-17
EJQ Wheel, Polishing Agent Dental Class 1 872.6010 2016-06-01
EIH Powder, Porcelain Dental Class 2 872.6660 2016-09-14
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 2012-09-05
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2004-01-16
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2015-11-02
EMA Cement, Dental Dental Class 2 872.3275 2008-01-31
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2010-12-13
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2010-12-13
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-01-31
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2015-06-19
NXC Aligner, Sequential Dental Class 2 872.5470 2024-04-18
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2008-01-31
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2020-02-28
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2016-05-23
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2008-12-17
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2010-02-25
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2011-10-10
ELW Material, Impression Dental Class 2 872.3660 2010-02-25
EMA Cement, Dental Dental Class 2 872.3275 2009-06-22
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2023-06-19
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2003-05-13
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-01-14
EMA Cement, Dental Dental Class 2 872.3275 2008-01-31
EIH Powder, Porcelain Dental Class 2 872.6660 2009-01-12
DZN Instruments, Dental Hand Dental Class 1 872.4565 2010-06-03
NFS Device, Jaw Tracking, For Monitoring Jaw Positions Dental Class 1 872.2060 2019-08-27
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2004-09-08
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2008-01-31
EMA Cement, Dental Dental Class 2 872.3275 2019-07-12
ELW Material, Impression Dental Class 2 872.3660 2008-01-14
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2008-01-14
EMA Cement, Dental Dental Class 2 872.3275 2020-12-09
ELW Material, Impression Dental Class 2 872.3660 2007-11-30
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2024-01-29
ELW Material, Impression Dental Class 2 872.3660 2007-11-30
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2008-01-31
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2010-02-25
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2008-01-14
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2015-09-15
ELW Material, Impression Dental Class 2 872.3660 2017-06-29
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2008-01-31
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2008-01-31
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2009-06-11
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2009-06-11
LBH Varnish, Cavity Dental Class 2 872.3260 2020-07-02
EMA Cement, Dental Dental Class 2 872.3275 2020-07-02
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2008-01-14
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2013-12-17
EIE Dam, Rubber Dental Class 1 872.6300 2008-01-31
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2008-01-31
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2024-01-29
ELW Material, Impression Dental Class 2 872.3660 2010-02-25
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2008-01-31
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2013-08-09
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2008-04-17
EIH Powder, Porcelain Dental Class 2 872.6660 2007-11-30
EMA Cement, Dental Dental Class 2 872.3275 2018-04-06
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2020-08-18
ELW Material, Impression Dental Class 2 872.3660 2008-01-14
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2016-03-03
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2014-09-18
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2008-01-31
EJH Alloy, Metal, Base Dental Class 2 872.3710 2012-12-05
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2008-01-31
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2008-01-31
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2008-01-31
EIH Powder, Porcelain Dental Class 2 872.6660 2016-07-01
LBH Varnish, Cavity Dental Class 2 872.3260 2011-01-04
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2013-12-17
EMA Cement, Dental Dental Class 2 872.3275 2008-01-31
EBD Coating, Filling Material, Resin Dental Class 2 872.3310 2006-03-20
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2008-01-31
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2008-01-31
LBH Varnish, Cavity Dental Class 2 872.3260 2009-07-30
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2009-07-30
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2009-07-30
EMA Cement, Dental Dental Class 2 872.3275 2010-02-25
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2010-04-27
ELW Material, Impression Dental Class 2 872.3660 2018-07-13
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2013-12-17
EMA Cement, Dental Dental Class 2 872.3275 2008-01-31
ELW Material, Impression Dental Class 2 872.3660 2008-01-14

Official Correspondent

Futoshi Fusejima

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GC America Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3027555943 GC Corporation Mishima Factory Sunto-Gun Shizuoka, JP
3004146043 GC ASAHI CORPORATION AICHI, JP
3001949270 WINNING APPLIANCE MANUFACTORY LIMITED CHAI WAN HONG KONG Xinjiang, CN
3004046512 TSUEN LEE METALS & PLASTIC TOYS FACTORY SHEN ZHEN CITY Guangdong, CN
9710611 STICK TECH LTD. TURKU Pirkanmaa, FI

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K800400 Dentsply Intl. MAXUM DENTURE RESIN 1980-03-12
K033020 Cmp Industries, LLC IMPAK ACRYLIC REPAIR RESIN LIQUID 2003-12-19
K952662 Jeneric/Pentron, Inc. COMP=FLOW 1995-08-28
K171147 Bisco, Inc. REVEAL Bulk 2017-08-04
K770922 Espe GmbH (Us) DENTAL RESTORATIVE IN CAPSULES 1977-06-01

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0028-2020 Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 2
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0017-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017 Ivoclar Vivadent, Inc. 2
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1410097. Last updated year: 2026. Please use registration number 1410097 when referencing this establishment in official correspondence.
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