Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612300

FEI Number

3002808289

Entity Name

GC CORP.

City/State/Country

ITABASHI-KU Tokyo, JP

Establishment Address

76-1 HASUNUMA-CHO, ITABASHI-KU Tokyo 174-8585, JP

Establishment Type(s)

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

Expiration Date (Year)

2026

510(k) Number

K980695

PMA Number

N/A

All Registered 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 Cavity Conditioner 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMA	Cement, Dental	Dental	Class 2	872.3275	2010-02-25
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-09-25
EMA	Cement, Dental	Dental	Class 2	872.3275	2025-09-25
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2008-06-11
EMA	Cement, Dental	Dental	Class 2	872.3275	2016-07-13
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-07-01
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-01-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-01-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2016-07-13
EFD	Amalgamator, Dental, Ac-Powered	Dental	Class 1	872.3100	2009-09-16
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2008-01-31
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-01-14
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2008-01-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2018-03-22
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2023-06-19
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-09-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-14
ELW	Material, Impression	Dental	Class 2	872.3660	2012-11-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2008-03-07
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-31
ELW	Material, Impression	Dental	Class 2	872.3660	2008-01-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2010-02-25
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-09-25
EMA	Cement, Dental	Dental	Class 2	872.3275	2025-09-25
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2025-09-25
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2025-09-25
EMA	Cement, Dental	Dental	Class 2	872.3275	2019-07-12
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-14
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-01-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2020-12-09
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-01-05
EMA	Cement, Dental	Dental	Class 2	872.3275	2009-06-22
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2014-03-27
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2014-03-27
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	2008-01-31
LFD	Saliva, Artificial	Unknown	Class U	N/A	2011-01-31
EMA	Cement, Dental	Dental	Class 2	872.3275	2010-09-20
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2006-03-20
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2003-05-13
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2015-04-01
EMA	Cement, Dental	Dental	Class 2	872.3275	2012-11-28
ELW	Material, Impression	Dental	Class 2	872.3660	2007-11-30
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
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2008-01-31
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2011-01-04
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2010-02-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2010-02-04
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2009-01-27
ELW	Material, Impression	Dental	Class 2	872.3660	2008-01-14
NYH	Plaque Disclosing Kit	Dental	Class 2	872.1740	2008-06-19
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-31
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-31
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2009-08-18
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-01-31
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-01-31
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2014-12-02
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2020-08-18
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2019-11-25
ELW	Material, Impression	Dental	Class 2	872.3660	2017-06-29
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2008-01-31
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2008-01-31
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-31

Official Correspondent

Futoshi Fusejima

US Agent Details

Futoshi Fusejima Business: GC America Inc. Email: futoshi.fusejima@gc.dental Phone: (708) 9263050

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
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09
K940030	Bisco, Inc.	BISCO COMPOSITE	1994-02-04

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

Similar Registrations

Registration Number	Establishment Name	Location
8030419	SUN MEDICAL CO., LTD.	Moriyama Shiga, JP
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3035693034	Solventum Germany GmbH	Kist Bavaria, DE
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3003775534	GC EUROPE N.V.	LEUVEN Vlaams Brabant, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612300. Last updated year: 2026. Please use registration number 9612300 when referencing this establishment in official correspondence.