Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613953

FEI Number

3002807052

Entity Name

GC DENTAL PRODUCTS CORP.

City/State/Country

KASUGAI-SHI Aichi, JP

Establishment Address

2-285 TORIIMATSU-CHO, KASUGAI-SHI Aichi 486-0844, 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

K040567

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELW	Material, Impression	Dental	Class 2	872.3660	2008-01-14
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2003-05-13
EMA	Cement, Dental	Dental	Class 2	872.3275	2016-07-13
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2014-03-10
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2012-11-28
EIE	Dam, Rubber	Dental	Class 1	872.6300	2004-12-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2019-11-25
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-01-14
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-12-17
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2018-03-22
LFD	Saliva, Artificial	Unknown	Class U	N/A	2011-01-31
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
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2015-07-22
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2018-11-20
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-06-09
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2008-01-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2014-06-03
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-01-14
ELW	Material, Impression	Dental	Class 2	872.3660	2008-01-14
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2008-01-31
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2015-04-22
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-07-20
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2008-01-31
ELW	Material, Impression	Dental	Class 2	872.3660	2012-05-16
ELW	Material, Impression	Dental	Class 2	872.3660	2010-02-25
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2010-02-25
ELW	Material, Impression	Dental	Class 2	872.3660	2008-04-22
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2010-02-25
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-14
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2008-01-14
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
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2014-09-18
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2008-01-30
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
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2016-07-13
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-30

Official Correspondent

Futoshi Fusejima

US Agent Details

Futoshi Fusejima Business: GC America Inc. Email: futoshi.fusejima@gc.dental Phone: (708) 5970900

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
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13
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

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613953. Last updated year: 2026. Please use registration number 9613953 when referencing this establishment in official correspondence.