Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002807050

FEI Number

3002807050

Entity Name

GC CORPORATION-FUJI OYAMA FACTORY

City/State/Country

SUNTO-GUN, Shizuoka-Ken, JP

Establishment Address

584-1 NAKAHINATA OYAMA-CHO, SUNTO-GUN, Shizuoka-Ken 410-1307, 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

K961417

PMA Number

N/A

All Registered 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 Cavity Conditioner 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

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
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-31
ELW	Material, Impression	Dental	Class 2	872.3660	2018-07-13
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2015-04-01
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-01-31
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-31
EMA	Cement, Dental	Dental	Class 2	872.3275	2018-04-06
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-01-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-01-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2010-02-25
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-01-31
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-31
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-01-14
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2004-09-08
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-07-01
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-01-14
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
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-31
EMA	Cement, Dental	Dental	Class 2	872.3275	2010-02-25
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2008-01-31
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2008-01-31
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2011-01-04
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-31
EMA	Cement, Dental	Dental	Class 2	872.3275	2009-06-22
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-31
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2016-03-03
ELW	Material, Impression	Dental	Class 2	872.3660	2017-06-29
EMA	Cement, Dental	Dental	Class 2	872.3275	2010-02-25
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2006-03-20
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2008-04-17
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-09-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-14
ELW	Material, Impression	Dental	Class 2	872.3660	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	2008-01-31
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2005-11-18
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2008-01-31

Official Correspondent

Futoshi Fusejima

US Agent Details

Futoshi Fusejima Business: GC America Inc. Email: futoshi.fusejima@gc.dental Phone: (708) 9263261

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-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
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

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 3002807050. Last updated year: 2026. Please use registration number 3002807050 when referencing this establishment in official correspondence.