Manufacturer registered with FDA

GC America Inc.

Alsip, IL, United States. Lists 43 dental device types with FDA across 13 registered establishments, and holds 137 510(k) clearances as applicant.

FDA owner/operator8030268Contract manufacturerForeign exporterManufacturerRemanufacturer7 clearances in five years

Device types listed: 43
Brands and models: 405
510(k) clearances: 1371993–2026
Markets registered in: 161,619 registrations outside the US
Establishments: 13Austria, Belgium, China +4

510(k) clearances per year, 1990–2026

Registered in 16 markets

Where regulators' registries name GC America Inc. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	GC America Inc.	137 clearances	1993–2026	Below
Canada	Health Canada	Registration holder	GC AMERICA INC.KLEMA DENTALPRODUKTE GMBH · GC EUROPE N.V.	656	1999–2025	Pure Global AI
Saudi Arabia	SFDA	Manufacturer	GC EUROPE N.V.GC Europe N.V.	216	—	Pure Global AI
Taiwan	TFDA	Manufacturer	GC CORPORATION FUJI OYAMA FACTORYGC DENTAL PRODUCTS CORPORATION · GC EUROPE N.V. · +2	159	1998–2026	Pure Global AI
Colombia	INVIMA	Manufacturer	GC AMERICA INC.GC DENTAL PRODUCTS CORP. · GC DENTAL PRODUCTS CORP · +2	156	—	Pure Global AI
South Korea	MFDS	Manufacturer	GC Corporation Fuji Oyama FactoryGC Dental Products Corporation · GC AMERICA INC · +2	155	1998–2026	Pure Global AI
Serbia	ALIMS	Manufacturer	GC Europe N.V.KLEMA Dentalprodukte GmbH	125	2024–2026	Pure Global AI
Australia	TGA	Manufacturer	GC Europe NVGC Dental Products Corporation	42	2015–2026	Pure Global AI
Brazil	ANVISA	Manufacturer	GC AMERICA INC.KLEMA DENTALPRODUKTE GMBH · GC DENTAL PRODUCTS CORPORATION · +2	41	1999–2024	Pure Global AI
Costa Rica	Ministerio de Salud	Manufacturer	GC America Inc.GC AMERICA, INC · GC AMERICA, INC.	33	—	Pure Global AI
Peru	DIGEMID	Manufacturer	GC AMERICA INCGC DENTAL PRODUCTS CORPORATION	13	2009–2022	Pure Global AI
Israel	AMAR	Manufacturer	GC EuropeGC America Inc. · GC Europe NV · +2	10	—	Pure Global AI
Hong Kong	MDD	Manufacturer	GC Dental Products Corporation	6	2021–2026	Pure Global AI
China	NMPA	Registration holder	而至欧洲株式会社GC Europe N.V.而至陶齿工业株式会社株式会社ジーシーデンタルプロダクツ GC Dental Products Corporation · 艾姆登牙科陶瓷有限公司KLEMA Dentalprodukte GmbH	4	—	Pure Global AI
United Kingdom	MHRA	Manufacturer	KLEMA Dentalprodukte GmbH	2	—	Pure Global AI
European Union	EUDAMED	Manufacturer	GC Europe NV	1	—	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What GC America Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Dental CementEMA · Class 2	Dental cements	Maker	BULK FujiCEM(AutoCompatible)CAVITRONCeramic PrimerCeramic Primer IICeramic Primer II Unit DoseCOE TEMP ADVANTAGECOE-PAK AUTOMIX NDSCoe-Pak Hard & Fast Set Standard PakCoe-Pak Standard PkgElite Cement 100 71 more EQUIAEQUIA CoatEQUIA FilEQUIA ForteEQUIA Forte CoatEQUIA Forte FilEQUIA Forte HT FilEQUIA LC ONEFreegenolFUJIFuji DuetFuji Filling LCFuji Filling LC Self ConditionerFUJI IFUJI IIFUJI II LCFUJI II LC (IMPROVED)Fuji IXFuji IX ARTFUJI IX GPFuji Lining LC Paste PakFuji PlusFuji TriageFuji VarnishG-aenial Injectable ProG-aenial Injectable Pro BulkG-aenial Universal Injectable IIG-CemG-CEM AutomixG-CEM CAPSULEG-Cem LinkForceG-Cem LinkForce Try-In PasteG-CEM ONEG-CEM Try-in PasteG-CEM VeneerG-Multi PrimerG-Premio Bond DCAGC Dual Cure ActivatorGC Fuji Automix LCGC Fuji DirectGC Fuji Filling LCGC Fuji Filling LC Self ConditionerGC Fuji IX GP CapsuleGC FUJI IX GP EXTRAGC Fuji IX GP FASTGC Fuji Lining LC Paste PakGC Fuji PLUSGC Fuji PLUS CAPSULEGC Fuji PLUS CONDITIONERGC FUJI TEMPGC Fuji TriageGC Fuji Triage EPGC FUJICEMGC FujiCEM 2 (Improved)GC FujiCEM EvolveGC Fujii Plus No EtchGC GAM-100GC Gold Label 1 Luting and LiningGC Gold Label 2 Univ. RestGC Gold Label 9 HS Post. Rest.GC Gold Label HybridGC Lining CementGC TEMP ADVANTAGEGradia Direct LofloGVC-100Miracle MixMIRACLE MIX CAPSULEMulti PrimerNogenol Temporary CementTemp Advantage76 EMA LINING CEMENT	2007
Resin Tooth Shade MaterialEBF · Class 2	Dental composites	Maker	CerasmartCerasmart 270Cerasmart UniversalDiapolisher PasteEQUIA LC ONEEssentiaEssentia UniversaleverX FloweverX PosteriorFoundation 37 more FUJI II LC CAPSULEG-aenial A-ChordG-aenial Bulk InjectableG-aenial FloG-aenial Flo XG-aenial Injectable ProG-aenial Injectable Pro BulkG-aenial Injection Matrix KitG-aenial SculptG-aenial Universal FloG-aenial Universal Injectable IIG-aenial Universal Injectable NMF004AG-FixGC Gradia Diamond PolisherGC KaloreGC Ortho Connect FlowGDLS-200GradiaGradia Composite ResinGRADIA COREGradia Diapolisher PasteGradia DirectGradia Direct FloGradia Direct LofloGRADIA DIRECT XGradia ForteGRADIA GUMGradia PlusGradia PremiHTFX-222MFP-051MI FilMI FlowSOLARESOLARE BULKSOLARE PSRGC-06	2008
Rebasing Repairing Relining Denture ResinEBI · Class 2	Denture resins & teeth	Maker	Coe ComfortCoe LubricantCoe SoftCoe Soft PrintCoe-RecteverStickC&BeverStickNETeverStickORTHOeverStickPERIOfibreNet 24 more fibreStickFoundationGC BaselineGC RelineGC Reline (Primer, Modifier, BondinGC Reline Bonding AgentGC Reline IIGC Reline ModifierGC Reline Powder, LiquidGC Reline Primer MGC Reline Primer RGC RELINE SOFT/EXTRA SOFTKoolinerNature Cryl HI PlusNature Cryl HI-20ETNature-Cryl MCNature-Cryl PourNature-Cryl Super HI ImpactNew PlastoneStickStickNETSuper-SoftUnifast IIIUnifast Trad	2008
Impression MaterialELW · Class 2	Impression materials	Maker	AIM2Aroma FineAroma Fine PlusCoe AlginateCoe Hydrophilic Gel (GHG)Coe Ortho AlginateCoe Tray AdhesiveCoe-CalCoe-FlexDispensing Guns Plunger for Universal Dispenser 31 more Exa AdvanceEXA AdvancedEXA'LenceExa'Lence FastExa'Lence PuttyExabite II NDSExaClearEXAFAST NDSEXAFAST PUTTYExaflexEXAFLEX IMPRESSION MATERIALExajetExalence 370EXAMIX NDSFIT CHECKERFit Checker AdvancedFIT CHECKER IIFusion FastFusion PuttyGC BLUE SILICONEGC Cartridge DispenserGC Cartridge Dispenser II PlungerGC Initial BrushGC Pas/CionImpreceedIntraoral Tips Universal/NDSISO FunctionalMixing TipsOmniflexUniversal VPS Adhesive76 ELW BITE CHECKER SILICONE	2007
Porcelain PowderEIH · Class 2	Dental ceramics & zirconia	Maker	Aadva Zr Coloring LiquidCreationCreation CCCREATION CP-ZI PORCELAINCreation LSCreation Magic ColourCreation ZI-CT, ZI-FFujivest IIG-Cera Orbit ColorG-Cera Orbit LC 29 more GC Aadva Zr DiskGC FujiVestGC Initial Zirconia Disk HTGC Initial Zirconia Disk STGC Initial ZR Disk HTGC Initial ZR Disk ML EliteGC Lisi Press VestGC-ZIRCONIAInitialInitial BrushInitial IQInitial IQ SQINInitial LiSiInitial LiSi BlockInitial LiSi PressInitial Lustre Paste OneInitial Lustre Pastes NFInitial OneInitial PCInitial Spectrum StainsInitial TILisi PressVestMSCB-001WILLI GELLER CREATION & AV PORCELAINWILLI GELLER CREATION AND LF PORCELAINWILLI GELLER CREATION CP PORCELAINWILLI GELLER CREATION II PORCELAINWILLI GELLER CREATION PORCELAINWILLI GELLER CREATION ZI PORCELAIN	2007
Resin Tooth Bonding AgentKLE · Class 2	Bonding agents	Maker	BZF-29Cavity ConditionerFUJI BOND LCG-2 Bond Universal KitG-aenial BondG-aenial Bond Unit DoseG-BondG-Bond PlusG-Premio BondG2-Bond Universal 5 more GC Acrylic PrimerGC FUJI COAT LCMETALPRIMER IISolare Universal BondUniFil Bond	2008
Resin Temporary Crown and BridgeEBG · Class 2	Temporary crown & bridge materials	Maker	AlikeCerasmartCerasmart 270Cerasmart UniversalFixpeedGC Pattern ResinGC Temp PRINTMSN-006Pattern Resin LSTEMPSMART 3 more Unifast IIIUnifast LCUnifast Trad	2008
Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2	—	Maker	Fuji Ortho LCG-aenial Injectable ProG-aenial Injectable Pro BulkG-aenial Universal Injectable IIGC Aligner ConnectGC FUJI ORTHOGC Fuji Ortho Band LC AutomixGC Fuji ORTHO BAND LC PASTE PAKGC Fuji ORTHO BAND PASTE PAKGC Fuji ORTHO LC 12 more GC Fuji Ortho LC Paste Pak AutomixGC FUJI ORTHO SCGC Gel ConditionerGC KommonBaseGC Mixing Tips for OrthoGC OPA-100GC OPB-100GC Ortho ConnectGC Ortho Etching GelJC-50ORTHO CONDITIONERORTHO GEL CONDITIONER	2008
Oral Cavity Abrasive Polishing AgentEJR · Class 1	Polishing & prophylaxis	Maker	GC Tooth MousseGC Tooth Mousse PlusMI PasteMI Paste PlusMI Prophy Polish	2004
Cavity VarnishLBH · Class 2	Sealants & varnishes	Maker	G-aenial Injection Matrix KitG-aenial Universal FloGC Fuji Triage EPMI FilMI Varnish	2009
Pit and Fissure Sealant and ConditionerEBC · Class 2	Sealants & varnishes	Maker	EssentiaG-aenial FloG-aenial Injectable ProG-aenial Injectable Pro BulkG-aenial Injection Matrix KitG-aenial Universal FloG-aenial Universal Injectable IIG-BondMI FilMI Flow 1 more Revotek LC	2009
Resin Filling Material CoatingEBD · Class 2	—	Maker	FoundationG-COATG-Coat PlusGC OptiglazeNanocoat ColorOptiglaza ColorOptiglaze	2006
Endosseous Dental Implant AbutmentNHA · Class 2	Implant abutments	Maker	GC AADVA ABUTMENTGC Aadva Abutments Zirconium - BO, AC, BH, SVGC Aadva BlendGC AADVA BO AC ABUTMENTSGC Aadva Implant SystemJNE Implant System	2008
Synthetic Bone Grafting MaterialLYC · Class 2	Bone grafts & membranes	Maker	Cytrans ElashieldCytrans GranulesFoundation	2020
Root-Form Endosseous ImplantDZE · Class 2	Dental implants	Maker	GC Aadva Implant SystemJNE Implant System	2010
Ultraviolet Activator for PolymerizationEBZ · Class 2	Curing lights	Maker	G-LIGHTSilverlightThe LightThe Light 405	2005
Restorative and Impression Material SyringeEID · Class 1	Dental hand instruments	Maker	Coe SyringeGC Cartridge Dispenser IIGC SyringeImpression SyringesMixing TipsTempsmart Mixing Tips	1998
Dental Instrument HandleEJB · Class 1	Dental hand instruments	Maker	Applicator HolderAPPLIER IIIApplier IVGC Capsule Applier VGC Fuji Capsule ApplierGC Initial BrushGradia Brush TipsMicrotip ApplicatorOptiglaze TipsPaste Pak Dispenser 2 more Paste Pak Dispenser IIUnitip Applier II	2003
Intraoral Dental WaxEGD · Class 1	—	Maker	GC BITE COMPOUNDSALIVA CHECK	2004
Rubber DamEIE · Class 1	Rubber dam systems	Maker	GC ConditionerGC TiON Gingival Protector	2004
Orthodontic Space Preformed MaintainerDYT · Class 1	Retainers, expanders & headgear	Maker	everStickORTHO	2013
Dental Hand InstrumentsDZN · Class 1	Dental hand instruments	Maker	Fuji SpatulaGC Occlusal MatrixStickCARRIERStickSTEPPER	2010
Ac-Powered Dental AmalgamatorEFD · Class 1	—	Maker	Capsule Mixer CM-IISympress 120	2009
Silicate ProtectorEFX · Class 1	—	Maker	StickREFIX	2013
Polishing Agent StripEHM · Class 1	Polishing & prophylaxis	Maker	EPITEXEPITEX FINISHINGGC Metal StripsPOLISHING STRIPSUltimate Finishing & Polishing Kit	2005
Calcium Hydroxide Cavity LinerEJK · Class 2	—	Maker	FUJI LINING CEMENT LIGHT CURE	2008
Root Canal PostELR · Class 1	Root canal filling materials	Maker	EVERSTICK POSTGC Fiber Post	2009
Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2	Intraoral scanners	Maker	Aadva Lab Scanner 2Aadva Lab Scanner 3Coe CalFujiRockGC Aadva IOSGC Aadva IOS 100PGC Aadva IOS 200GC Aadva ScannerLD-1 Milling Machiine	2011
Plaque Disclosing KitNYH · Class 2	—	Maker	GC Tri Plaque ID Gel	2008
Orthodontic Plastic BracketDYW · Class 2	Orthodontic brackets	Maker	EVERSTICK A&O	2013
Intraoral Dental DrillDZA · Class 1	Surgical drills & motors	Maker	GC Fiber Post Drill	2009
Amalgam Dental CapsuleDZS · Class 1	—	Maker	Capsule Applier III	2026
Resin Impression Tray MaterialEBH · Class 1	Impression trays	Maker	Coe Tray Plastic	2012
Articulation PaperEFH · Class 1	—	Lister	Articulating Paper	2026
Preformed Impression TrayEHY · Class 1	Impression trays	Maker	Check Bite TrayCoe Sideless Impression TrayDepressed Anterior TrayMcGowan -Winkler Impression TrayPerforated TrayRegular and Partial TraySpacer TrayStainless Steel TraySto-K Tray	2015
Crown RemoverEIS · Class 1	Dental hand instruments	Maker	Dupli Coi Loid	2001
Base Metal AlloyEJH · Class 2	Dental alloys	Maker	Aadva Ti Coloring Service	2012
Polishing Agent WheelEJQ · Class 1	Polishing & prophylaxis	Lister	Ultimate F&P Kit	2016
Porcelain TeethELL · Class 2	Dental ceramics & zirconia	Maker	WILLI GELLER CREATION CP PORCELAIN	2014
Teeth Plastic DentureELM · Class 2	Denture resins & teeth	Maker	WILLI GELLER CREAPEARL	2014
Root Canal Filling ResinKIF · Class 2	Root canal filling materials	Maker	Nogenol Root Canal Sealer	2015
Jaw Tracking Device for Monitoring Jaw PositionsNFS · Class 1	—	Lister	Dental Prescale II	2019
Sequential AlignerNXC · Class 2	Clear aligners	Maker	Eon Aligner	2024

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names GC America Inc. as the applicant, including filings under its other names.

Decided	510(k)	Device	Device type
10 Sep 2026	K262202	Cerasmart Forte	EBF Resin Tooth Shade Material
6 Jul 2026	K253317	Cytrans Elashield	LYC Synthetic Bone Grafting Material
18 Jun 2026	K261246	SRGC-06	EBF Resin Tooth Shade Material
18 May 2026	K254109	G-CEM UNIVERSAL	EMA Dental Cement
2 Oct 2025	K251124	G-Bond Universal	KLE Resin Tooth Bonding Agent
19 Sep 2025	K250953	EQUIA LC ONE	EMA Dental Cement
29 Aug 2025	K251946	G aenial Universal Injectable II	EBF Resin Tooth Shade Material
24 Nov 2020	K200798	G-CEM ONE	EMA Dental Cement
2 Oct 2020	K200682	BZF-29	KLE Resin Tooth Bonding Agent
17 Aug 2020	K192597	Cytrans Granules	LYC Synthetic Bone Grafting Material
9 Jul 2020	K193113	GC Temp Print	EBG Resin Temporary Crown and Bridge
2 Jul 2020	K193484	GC Fuji Triage EP	EMA Dental Cement
22 Nov 2019	K192260	everX Flow	EBF Resin Tooth Shade Material
11 Jul 2019	K182854	GC FujiCEM 2 (Improved)	EMA Dental Cement
20 Nov 2018	K180917	GC Acrylic Primer	KLE Resin Tooth Bonding Agent
12 Jul 2018	K181011	AIM2	ELW Impression Material
2 Apr 2018	K172382	GC Fuji Direct	EMA Dental Cement
8 Mar 2018	K173500	NMF004A	EBF Resin Tooth Shade Material
13 Sep 2016	K153130	Initial LiSi Block	EIH Porcelain Powder
12 Jul 2016	K153325	Gradia Plus	EBF Resin Tooth Shade Material
6 Jul 2016	K153231	G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer	EMA Dental Cement
30 Jun 2016	K153136	Initial LiSi Press	EIH Porcelain Powder
20 May 2016	K153127	everX Posterior	EBF Resin Tooth Shade Material
25 Mar 2016	K152274	MSCB-001	EIH Porcelain Powder
3 Mar 2016	K153253	GC Reline II	EBI Rebasing Repairing Relining Denture Resin
9 Oct 2015	K151541	G-Fix	EBF Resin Tooth Shade Material
20 Apr 2015	K143140	G-Premio BOND	KLE Resin Tooth Bonding Agent
5 Sep 2014	K141562	MSN-006	EBG Resin Temporary Crown and Bridge
9 Apr 2014	K133182	HTFX-222	EBF Resin Tooth Shade Material
14 Mar 2014	K133824	CERASMART	EBF Resin Tooth Shade Material
6 Mar 2014	K133836	OPTIGLAZE COLOR	EBD Resin Filling Material Coating
23 Jul 2013	K123631	MFP-051	EBF Resin Tooth Shade Material
30 Jan 2013	K113816	GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV	NHA Endosseous Dental Implant Abutment
27 Jun 2012	K120243	GAM-200	EMA Dental Cement
10 May 2012	K120521	GC BLUE SILICONE	ELW Impression Material
30 Jun 2011	K103234	GC AADVA BO AC ABUTMENTS	NHA Endosseous Dental Implant Abutment
17 Jun 2011	K110871	FIT CHECKER ADVANCED	ELW Impression Material
22 Dec 2010	K102808	MI VARNISH	LBH Cavity Varnish
6 Dec 2010	K093749	GC AADVA IMPLANT SYSTEM	DZE Root-Form Endosseous Implant
17 Sep 2010	K101420	GC FUJI TEMP	EMA Dental Cement
29 Sep 2009	K092020	AADVA ZR COLORING LIQUID	EIH Porcelain Powder
22 Jul 2009	K091388	GCUC-505	EBF Resin Tooth Shade Material
17 Jun 2009	K091106	EQUIA	EMA Dental Cement
10 Jun 2009	K090747	MI FLOW (GCUC-450)	EBF Resin Tooth Shade Material
26 Nov 2008	K082740	GC AADVA ZR DISK	EIH Porcelain Powder
14 Nov 2008	K082434	GDLS-200	EBF Resin Tooth Shade Material
30 Oct 2008	K082171	GRADIA CORE	EBF Resin Tooth Shade Material
21 Oct 2008	K082768	G-BOND PLUS	KLE Resin Tooth Bonding Agent
11 Jun 2008	K080724	GC OPB-100	DYH Resin Bracket and Tooth Conditioner Adhesive
5 Jun 2008	K080478	GRADIA FORTE	EBF Resin Tooth Shade Material
11 Apr 2008	K073106	UNIFAST III	EBG Resin Temporary Crown and Bridge
10 Mar 2008	K072425	JNE IMPLANT SYSTEM	DZE Root-Form Endosseous Implant
20 Feb 2008	K073283	GC GAM-100	EMA Dental Cement
15 Feb 2008	K073588	GC MODELS OPA-100 AND JC-50	DYH Resin Bracket and Tooth Conditioner Adhesive
14 Feb 2008	K072100	GC AADVA ABUTMENT	NHA Endosseous Dental Implant Abutment
9 Aug 2007	K071674	GC-ZIRCONIA	EIH Porcelain Powder
15 May 2007	K070840	GVC-100	EMA Dental Cement
12 Apr 2007	K070854	GC MI PASTE PLUS	EJR Oral Cavity Abrasive Polishing Agent
29 Mar 2007	K070698	COE COMFORT	EBI Rebasing Repairing Relining Denture Resin
29 Mar 2007	K070697	COE SOFT	EBI Rebasing Repairing Relining Denture Resin
12 Mar 2007	K070190	GRADIA DIRECT X	EBF Resin Tooth Shade Material
26 Feb 2007	K070319	GC FUJI IX GP EXTRA	EMA Dental Cement
14 Jul 2006	K061535	GC XLC-100 CAPSULE	EMA Dental Cement
21 Mar 2006	K051953	EVERSTICK A&O	DYW Orthodontic Plastic Bracket
20 Oct 2005	K052462	G-COAT	EBD Resin Filling Material Coating
22 Aug 2005	K051427	GC FUJI FIL LC	EMA Dental Cement
7 Jul 2005	K051358	NATURE-CRYL HI PLUS	EBI Rebasing Repairing Relining Denture Resin
4 Mar 2005	K043493	FUSION PUTTY TYPE	ELW Impression Material
3 Feb 2005	K050059	G-LIGHT	EBZ Ultraviolet Activator for Polymerization
27 Jan 2005	K043471	FUSION FAST	ELW Impression Material
25 Jan 2005	K043301	GC TION GINGIVAL PROTECTOR	EIE Rubber Dam
18 Nov 2004	K042348	GRADIA DIRECT LOFLO	EBF Resin Tooth Shade Material
20 Oct 2004	K042200	MI PASTE	EJR Oral Cavity Abrasive Polishing Agent
29 Jun 2004	K041471	G-BOND	KLE Resin Tooth Bonding Agent
25 Jun 2004	K041398	GC FUSION	ELW Impression Material
22 Apr 2004	K040567	GC INITIAL MC, AL AND LF	EIH Porcelain Powder
2 Feb 2004	K033808	GRADIA GUM	EBF Resin Tooth Shade Material
29 Oct 2003	K031341	STICK FLOW	EBF Resin Tooth Shade Material
20 Oct 2003	K032289	FIT CHECKER II	ELW Impression Material
20 May 2003	K030820	EVERSTICK POST	ELR Root Canal Post
10 Apr 2003	K030072	EVERSTICK PERIO	EBI Rebasing Repairing Relining Denture Resin
30 Jan 2003	K023814	GRADIA DIRECT	EBF Resin Tooth Shade Material
22 Jan 2003	K023751	EXAJET	ELW Impression Material
16 Jan 2003	K023727	TEMPORARY CEMENT-DC010002	EMA Dental Cement
18 Oct 2002	K022430	ISO FUNCTIONAL	ELW Impression Material
13 May 2002	K021126	EVERSTICK ORTHO	EBI Rebasing Repairing Relining Denture Resin
3 May 2002	K021038	GC ELITE CEMENT 100	EMA Dental Cement
26 Apr 2002	K020578	GC FUJI ORTHO BAND PASTE PAK	DYH Resin Bracket and Tooth Conditioner Adhesive
28 Mar 2002	K020342	UNIFIL FLOW	EBF Resin Tooth Shade Material
28 Feb 2002	K020117	GC FUJI LINING LC PASTE PAK	EMA Dental Cement
20 Feb 2002	K013997	UNIFIL BOND	KLE Resin Tooth Bonding Agent
5 Nov 2001	K011799	EVERSTICKNET	EBI Rebasing Repairing Relining Denture Resin
5 Nov 2001	K011788	EVERSTICK	EBI Rebasing Repairing Relining Denture Resin
29 Oct 2001	K013198	FUJI VII CAPSULE	EMA Dental Cement
16 Oct 2001	K012542	REVOTEK LC	EBC Pit and Fissure Sealant and Conditioner
7 Aug 2001	K012134	GC E-LIGHT	EBZ Ultraviolet Activator for Polymerization
16 Jan 2001	K003817	PATTERN RESIN	EBG Resin Temporary Crown and Bridge
8 Jan 2001	K003334	STICK NET	EBI Rebasing Repairing Relining Denture Resin
4 Jan 2001	K003333	STICK	EBI Rebasing Repairing Relining Denture Resin
16 Aug 2000	K001823	LINKMAX	EMA Dental Cement
17 Jul 2000	K001730	GC FUJICEM	EMA Dental Cement
5 Jul 2000	K001518	GRADIA	EBF Resin Tooth Shade Material
27 Jan 2000	K994077	AROMA FINE (NORMAL AND FAST SET)	ELW Impression Material
11 Jan 2000	K993973	FUJI II LC CAPSULE	EBF Resin Tooth Shade Material
9 Jul 1999	K991774	ACRON MC MODIFICATION	EBI Rebasing Repairing Relining Denture Resin
28 May 1999	K990736	GC RELINE SOFT/EXTRA SOFT	EBI Rebasing Repairing Relining Denture Resin
25 Feb 1999	K984365	GC UNIFAST TRAD	EBI Rebasing Repairing Relining Denture Resin
4 Feb 1999	K984505	MIRACLE MIX POWDER/LIQUID	EMA Dental Cement
19 Oct 1998	K982695	GC RELINE	EBI Rebasing Repairing Relining Denture Resin
25 Jun 1998	K981461	GC FUJI ORTHO LC	DYH Resin Bracket and Tooth Conditioner Adhesive
16 Jun 1998	K981514	GC FUJI BOND LC	KLE Resin Tooth Bonding Agent
1 Jun 1998	K981370	MIRACLE MIX CAPSULE	EMA Dental Cement
13 Apr 1998	K980695	FUJI I	EMA Dental Cement
3 Apr 1998	K980682	FUJI II	EMA Dental Cement
21 Oct 1997	K973343	HYDROFLEX	ELW Impression Material
26 Aug 1997	K972594	METALPRIMER II	KLE Resin Tooth Bonding Agent
8 Apr 1997	K970656	HYDROFLEX	ELW Impression Material
29 Oct 1996	K963144	GC BASELINE	EBI Rebasing Repairing Relining Denture Resin
8 Jul 1996	K961448	FUJI IX GP	EMA Dental Cement
24 May 1996	K961584	FUJI II LC (IMPROVED)	EMA Dental Cement
24 May 1996	K961417	GC FUJI ORTHO	DYH Resin Bracket and Tooth Conditioner Adhesive
11 Mar 1996	K955932	EXAFLEX IMPRESSION MATERIAL (MODIFICATION)	ELW Impression Material
27 Sep 1995	K953166	FUJI BOND LC	KLE Resin Tooth Bonding Agent
23 May 1995	K951555	FUJI IX	EMA Dental Cement
8 Mar 1995	K950556	FUJI ORTHO LC	DYH Resin Bracket and Tooth Conditioner Adhesive
7 Feb 1995	K942993	THERMORESIN LC II	EBF Resin Tooth Shade Material
20 Jan 1995	K946100	FUJI DUET	EMA Dental Cement
18 Oct 1994	K942670	GC PATTERN RESIN	EBG Resin Temporary Crown and Bridge
12 Sep 1994	K943388	GC SURFLEX F	ELW Impression Material
4 May 1994	K940565	COE-SOFT LC	EBI Rebasing Repairing Relining Denture Resin
10 Mar 1994	K935961	GC FUJI COAT LC	KLE Resin Tooth Bonding Agent
4 Mar 1994	K935960	GC TEMPRON	EBG Resin Temporary Crown and Bridge
26 Jan 1994	K935261	KOOLINER II	EBI Rebasing Repairing Relining Denture Resin
21 Jan 1994	K930939	REBARON LC	EBI Rebasing Repairing Relining Denture Resin
6 Jan 1994	K935521	GC ELITE CEMENT	EMA Dental Cement
29 Sep 1993	K933206	EXA BITE REGISTRATION MATERIAL	ELW Impression Material
8 Jul 1993	K932039	G-CERA ORBIT COLOUR COMMUNICATION SET	EIH Porcelain Powder

Some of these clearances are listed with FDA today by another company: Five Star Orthodontic Laboratory & Supply, Inc. (2), GC Orthodontics (1), American Orthodontics (1), Sybron Dental Specialties (1).

Also lists devices cleared under other names

GC America Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: G-C Intl. Corp. (10), Jensen Industries, Inc. (7), Coe Laboratories, Inc. (6), GC Orthodontics (2), pritidenta GmbH (1), Olympus Terumo Biomaterials Corporation (1), Unix-Japan Co., Ltd. (1), Good Doctors Co., Ltd. (1).

Decided	510(k)	Device	Applicant	Device type
3 Feb 2017	K161025	priti multidisc ZrO2 High Translucent	pritidenta GmbH	EIH Porcelain Powder
16 Jul 2015	K150128	GC Ortho Connect, GC Ortho Etching Gel	GC Orthodontics	DYH Resin Bracket and Tooth Conditioner Adhesive
7 May 2015	K143667	GC KommonBase	GC Orthodontics	DYH Resin Bracket and Tooth Conditioner Adhesive
29 Nov 2011	K111087	FOUNDATION	Olympus Terumo Biomaterials Corporation	LYC Synthetic Bone Grafting Material
18 Nov 2011	K111709	FOUNDATION DENTAL RESIN	Unix-Japan Co., Ltd.	EBI Rebasing Repairing Relining Denture Resin
24 Feb 2010	K093751	CL-DC20, CL-DC21	Good Doctors Co., Ltd.	EBZ Ultraviolet Activator for Polymerization
7 Dec 2009	K092951	STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS	Mectron S.P.A.	EBZ Ultraviolet Activator for Polymerization
1 Mar 2007	K070114	CREATION CP-ZI PORCELAIN	Jensen Industries, Inc.	EIH Porcelain Powder
12 Jan 2005	K043468	WILLI GELLER CREATION II PORCELAIN	Jensen Int'L, Inc.	EIH Porcelain Powder
11 Jan 2005	K043201	WILLI GELLER CREATION ZI PORCELAIN	Jensen Industries, Inc.	EIH Porcelain Powder
20 Dec 2004	K043221	WILLI GELLER CREATION CP PORCELAIN	Jensen Industries, Inc.	EIH Porcelain Powder
13 Oct 2004	K040783	FOUNDATION	Terumo Corp.	LYC Synthetic Bone Grafting Material
27 Mar 2001	K010160	WILLI GELLER CREAPEARL	Jensen Industries, Inc.	ELM Teeth Plastic Denture
6 Nov 2000	K002904	WILLI GELLER CREATION AND LF PORCELAIN	Jensen Industries, Inc.	EIH Porcelain Powder
16 Aug 2000	K002041	WILLI GELLER CREATION & AV PORCELAIN	Jensen Industries, Inc.	EIH Porcelain Powder
22 Oct 1998	K981490	WILLI GELLER CREATION PORCELAIN	Jensen Industries, Inc.	EIH Porcelain Powder
16 Apr 1997	K970495	FOUNDATION INDIRECT COMPOSITE RESIN	Sybron Dental Specialties	EBF Resin Tooth Shade Material
30 Oct 1991	K913884	FUJI II LC	G-C Intl. Corp.	EMA Dental Cement
15 May 1991	K904135	FOUNDATION HYBRID COMPOSITE	Nulite Systems Research	EBD Resin Filling Material Coating
31 Jul 1990	K901999	FUJI LINING CEMENT LIGHT CURE	G-C Intl. Corp.	EJK Calcium Hydroxide Cavity Liner
22 Dec 1989	K894282	FIRST IMPRESSION TM	Coe Laboratories, Inc.	ELW Impression Material
26 Sep 1989	K894281	FIRST IMPRESSION WITH CHLORHEXIDINE	Coe Laboratories, Inc.	ELW Impression Material
17 Apr 1989	K890829	UNIFAST LC	G-C Intl. Corp.	EBG Resin Temporary Crown and Bridge
31 Oct 1988	K881422	COE PAK AUTO MIX, REGULAR OR HARD SET	Coe Laboratories, Inc.	EMA Dental Cement
16 May 1988	K880848	FUJI CAP II CAPSULE & APPLIER	G-C Intl. Corp.	EMA Dental Cement
1 May 1985	K851469	76 ELW BITE CHECKER SILICONE	G-C Intl. Corp.	ELW Impression Material
1 May 1985	K851468	76 EMA LINING CEMENT	G-C Intl. Corp.	EMA Dental Cement
18 Oct 1984	K842994	EMA FREEGENOL DENTAL CEMENT	Int'L Corp.	EMA Dental Cement
3 Jan 1984	K833261	INTERIM TEMP. CROWN & BRIDGE RESIN	Coe Laboratories, Inc.	EBG Resin Temporary Crown and Bridge
9 Apr 1982	K820673	SELF-CURING HARD DENTURE LINER	Coe Laboratories, Inc.	EBI Rebasing Repairing Relining Denture Resin
6 Oct 1981	K812680	G-C IMPRESSION SYRINGE	G-C Intl. Corp.	EID Restorative and Impression Material Syringe
6 Oct 1981	K812679	G-C FIT-CHECKER IMPRESSION MATERIAL	G-C Intl. Corp.	ELW Impression Material
6 Oct 1981	K812406	EXAFLEX IMPRESSION MATERIAL	G-C Intl. Corp.	ELW Impression Material
25 Sep 1981	K812568	CAVITRON	G-C Intl. Corp.	EMA Dental Cement
13 Dec 1979	K792427	PERMA-CRYL 20	Coe Laboratories, Inc.	EBI Rebasing Repairing Relining Denture Resin

Registered establishments

Establishment	Location	What it does
GC America Inc.FDA reg. 3045816931	Guanajuato Mexico, Mexico	Foreign exporter, Repacker / relabeler
GC AMERICA INC.FDA reg. 1410097	ALSIP, IL, United States	Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer, Repacker / relabeler
GC ASAHI CORPORATIONFDA reg. 3004146043	AICHI, Japan	Manufacturer
GC CORP.FDA reg. 9612300	ITABASHI-KU Tokyo, Japan	Complaint file establishment, Foreign exporter, Manufacturer, Repacker / relabeler
GC Corporation Mishima FactoryFDA reg. 3027555943	Sunto-Gun Shizuoka, Japan	Manufacturer
GC CORPORATION-FUJI OYAMA FACTORYFDA reg. 3002807050	SUNTO-GUN, Shizuoka-Ken, Japan	Complaint file establishment, Manufacturer, Repacker / relabeler
GC DENTAL PRODUCTS CORP.FDA reg. 9613953	KASUGAI-SHI Aichi, Japan	Complaint file establishment, Manufacturer
GC EUROPE N.V.FDA reg. 3003775534	LEUVEN Vlaams Brabant, Belgium	Manufacturer, Repacker / relabeler
Klema Dentalprodukte GMBHFDA reg. 3005974404	Meiningen Vorarlberg, Austria	Complaint file establishment, Manufacturer
NIMI CHEMICAL INDUSTRIAL CO., LTD.FDA reg. 3003941201	Kiryu Gunma, Japan	Manufacturer
STICK TECH LTD.FDA reg. 9710611	TURKU Pirkanmaa, Finland	Complaint file establishment, Manufacturer
TSUEN LEE METALS & PLASTIC TOYS FACTORYFDA reg. 3004046512	SHEN ZHEN CITY Guangdong, China	Manufacturer
WINNING APPLIANCE MANUFACTORY LIMITEDFDA reg. 3001949270	CHAI WAN HONG KONG Xinjiang, China	Manufacturer

Other names on FDA records

Stick Tech Ltd · GC Dental Products Corporation · GC Europe N.V. · GC Asahi Corporation · GC Corporation, Fuji Oyama Factory · KLEMA Dentalprodukte GmbH · Nimi Chemical Industrial Co., Ltd. · GC Corporation Mishima Factory · GC Corp. · Winning Appliance Manufactory Limited · Tsuen Lee Metals & Plastic Toys Factory

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8030268). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.