Data / Medical devices / United States / GC America Inc.

GC America Inc.: FDA-registered device maker in Alsip, IL, United States, 105 510(k) clearances

Name: GC America Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

GC America Inc. is registered with the FDA (registration 1410097) in Alsip, IL, United States. It lists 38 device types. The FDA files 105 510(k) clearances under its listings, the newest dated November 24, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1410097
Address: 3737 W 127th St, Alsip, IL, United States, 60803
Owner or operator: GC America Inc. (8030268)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler
First device listed: May 13, 2003
Registered through: 2026
Brand names listed: AIM2, APPLIER III, Aadva Lab Scanner 2, Aadva Lab Scanner 3, Aadva Ti Coloring Service, Alike, Applicator Holder, Applier IV and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Repackager or relabeler	accessdata.fda.gov
Activator, Ultraviolet, For Polymerization	EBZ	2	Repackager or relabeler	accessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, Resin	DYH	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Aligner, Sequential	NXC	2	Contract manufacturer	accessdata.fda.gov
Alloy, Metal, Base	EJH	2	Manufacturer	accessdata.fda.gov
Amalgamator, Dental, Ac-Powered	EFD	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Bone Grafting Material, Synthetic	LYC	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cement, Dental	EMA	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Coating, Filling Material, Resin	EBD	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dam, Rubber	EIE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Device, Jaw Tracking, For Monitoring Jaw Positions	NFS	1	Complaint file establishment	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Complaint file establishment	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Complaint file establishment	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Repackager or relabeler	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Maintainer, Space Preformed, Orthodontic	DYT	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Material, Impression	ELW	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Post, Root Canal	ELR	1	Repackager or relabeler	accessdata.fda.gov
Powder, Porcelain	EIH	2	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler	accessdata.fda.gov
Protector, Silicate	EFX	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Resin, Root Canal Filling	KIF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Saliva, Artificial	LFD	U	Manufacturer	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Sterilant, Medical Devices	MED	2	Repackager or relabeler	accessdata.fda.gov
Strip, Polishing Agent	EHM	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Complaint file establishment	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Manufacturer	accessdata.fda.gov
Varnish, Cavity	LBH	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	Complaint file establishment	accessdata.fda.gov
Wheel, Polishing Agent	EJQ	1	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 105.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 24, 2020	K200798	G-CEM ONE	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 2, 2020	K200682	BZF-29	KLE	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
August 17, 2020	K192597	Cytrans Granules	LYC	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
July 9, 2020	K193113	GC Temp Print	EBG	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
July 2, 2020	K193484	GC Fuji Triage EP	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
November 22, 2019	K192260	everX Flow	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
July 11, 2019	K182854	GC FujiCEM 2 (Improved)	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
November 20, 2018	K180917	GC Acrylic Primer	KLE	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
July 12, 2018	K181011	AIM2	ELW	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
April 2, 2018	K172382	GC Fuji Direct	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 8, 2018	K173500	NMF004A	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
February 3, 2017	K161025	priti multidisc ZrO2 High Translucent	EIH	Substantially Equivalent	Pritidenta GmbH	accessdata.fda.gov
September 13, 2016	K153130	Initial LiSi Block	EIH	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
July 12, 2016	K153325	Gradia Plus	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
July 6, 2016	K153231	G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 30, 2016	K153136	Initial LiSi Press	EIH	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
May 20, 2016	K153127	everX Posterior	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 25, 2016	K152274	MSCB-001	EIH	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 3, 2016	K153253	GC Reline II	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 9, 2015	K151541	G-Fix	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
April 20, 2015	K143140	G-Premio BOND	KLE	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
September 5, 2014	K141562	MSN-006	EBG	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
April 9, 2014	K133182	HTFX-222	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 14, 2014	K133824	CERASMART	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 6, 2014	K133836	OPTIGLAZE COLOR	EBD	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
July 23, 2013	K123631	MFP-051	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
November 29, 2011	K111087	FOUNDATION	LYC	Substantially Equivalent	Olympus Terumo Biomaterials Corporation	accessdata.fda.gov
November 18, 2011	K111709	FOUNDATION DENTAL RESIN	EBI	Substantially Equivalent	Unix-Japan Co., Ltd.	accessdata.fda.gov
January 27, 2011	K101346	GC ORAL MOISTURIZING GEL	LFD	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
December 22, 2010	K102808	MI VARNISH	LBH	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
December 6, 2010	K093749	GC AADVA IMPLANT SYSTEM	DZE	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
February 24, 2010	K093751	CL-DC20, CL-DC21	EBZ	Substantially Equivalent	Good Doctors Co., Ltd.	accessdata.fda.gov
December 7, 2009	K092951	STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS	EBZ	Substantially Equivalent	Mectron S.P.A.	accessdata.fda.gov
July 22, 2009	K091388	GCUC-505	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 17, 2009	K091106	EQUIA	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 10, 2009	K090747	MI FLOW (GCUC-450)	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
November 26, 2008	K082740	GC AADVA ZR DISK	EIH	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
November 14, 2008	K082434	GDLS-200	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 21, 2008	K082768	G-BOND PLUS	KLE	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 11, 2008	K080724	GC OPB-100	DYH	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
April 11, 2008	K073106	UNIFAST III	EBG	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
February 20, 2008	K073283	GC GAM-100	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
February 15, 2008	K073588	GC MODELS OPA-100 AND JC-50	DYH	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
April 12, 2007	K070854	GC MI PASTE PLUS	EJR	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 29, 2007	K070698	COE COMFORT	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 29, 2007	K070697	COE SOFT	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
July 14, 2006	K061535	GC XLC-100 CAPSULE	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 20, 2005	K052462	G-COAT	EBD	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
August 22, 2005	K051427	GC FUJI FIL LC	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
July 7, 2005	K051358	NATURE-CRYL HI PLUS	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 4, 2005	K043493	FUSION PUTTY TYPE	ELW	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
January 27, 2005	K043471	FUSION FAST	ELW	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
January 25, 2005	K043301	GC TION GINGIVAL PROTECTOR	EIE	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 20, 2004	K042200	MI PASTE	EJR	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 13, 2004	K040783	FOUNDATION	LYC	Substantially Equivalent	Terumo Corp.	accessdata.fda.gov
June 29, 2004	K041471	G-BOND	KLE	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 25, 2004	K041398	GC FUSION	ELW	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
April 22, 2004	K040567	GC INITIAL MC, AL AND LF	EIH	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 20, 2003	K032289	FIT CHECKER II	ELW	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
April 10, 2003	K030072	EVERSTICK PERIO	EBI	Substantially Equivalent	Stick Tech , Ltd.	accessdata.fda.gov
January 30, 2003	K023814	GRADIA DIRECT	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
January 22, 2003	K023751	EXAJET	ELW	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
January 16, 2003	K023727	TEMPORARY CEMENT-DC010002	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 18, 2002	K022430	ISO FUNCTIONAL	ELW	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
May 13, 2002	K021126	EVERSTICK ORTHO	EBI	Substantially Equivalent	Stick Tech , Ltd.	accessdata.fda.gov
April 26, 2002	K020578	GC FUJI ORTHO BAND PASTE PAK	DYH	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 28, 2002	K020342	UNIFIL FLOW	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
February 28, 2002	K020117	GC FUJI LINING LC PASTE PAK	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
November 5, 2001	K011799	EVERSTICKNET	EBI	Substantially Equivalent	Stick Tech , Ltd.	accessdata.fda.gov
November 5, 2001	K011788	EVERSTICK	EBI	Substantially Equivalent	Stick Tech , Ltd.	accessdata.fda.gov
October 29, 2001	K013198	FUJI VII CAPSULE	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 16, 2001	K012542	REVOTEK LC	EBC	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
January 16, 2001	K003817	PATTERN RESIN	EBG	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
January 8, 2001	K003334	STICK NET	EBI	Substantially Equivalent	Stick Tech , Ltd.	accessdata.fda.gov
January 4, 2001	K003333	STICK	EBI	Substantially Equivalent	Stick Tech , Ltd.	accessdata.fda.gov
August 16, 2000	K001823	LINKMAX	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
July 5, 2000	K001518	GRADIA	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
January 27, 2000	K994077	AROMA FINE (NORMAL AND FAST SET)	ELW	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
July 9, 1999	K991774	ACRON MC MODIFICATION	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
February 25, 1999	K984365	GC UNIFAST TRAD	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 19, 1998	K982695	GC RELINE	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 25, 1998	K981461	GC FUJI ORTHO LC	DYH	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
April 16, 1997	K970495	FOUNDATION INDIRECT COMPOSITE RESIN	EBF	Substantially Equivalent	Sybron Dental Specialties, Inc.	accessdata.fda.gov
October 29, 1996	K963144	GC BASELINE	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 11, 1996	K955932	EXAFLEX IMPRESSION MATERIAL (MODIFICATION)	ELW	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
May 23, 1995	K951555	FUJI IX	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 8, 1995	K950556	FUJI ORTHO LC	DYH	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
January 20, 1995	K946100	FUJI DUET	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
December 6, 1994	K931592	METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE	MED	Substantially Equivalent	Metrex Research Corp.	accessdata.fda.gov
December 6, 1994	K931052	METRICIDE 28	MED	Substantially Equivalent	Metrex Research Corp.	accessdata.fda.gov
October 18, 1994	K942670	GC PATTERN RESIN	EBG	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
January 26, 1994	K935261	KOOLINER II	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
September 29, 1993	K933206	EXA BITE REGISTRATION MATERIAL	ELW	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
July 8, 1993	K932039	G-CERA ORBIT COLOUR COMMUNICATION SET	EIH	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
May 15, 1991	K904135	FOUNDATION HYBRID COMPOSITE	EBD	Substantially Equivalent	Nulite Systems Research	accessdata.fda.gov
December 22, 1989	K894282	FIRST IMPRESSION TM	ELW	Substantially Equivalent	Coe Laboratories, Inc.	accessdata.fda.gov
September 26, 1989	K894281	FIRST IMPRESSION WITH CHLORHEXIDINE	ELW	Substantially Equivalent	Coe Laboratories, Inc.	accessdata.fda.gov
April 17, 1989	K890829	UNIFAST LC	EBG	Substantially Equivalent	G-C Intl. Corp.	accessdata.fda.gov
October 31, 1988	K881422	COE PAK AUTO MIX, REGULAR OR HARD SET	EMA	Substantially Equivalent	Coe Laboratories, Inc.	accessdata.fda.gov
January 3, 1984	K833261	INTERIM TEMP. CROWN & BRIDGE RESIN	EBG	Substantially Equivalent	Coe Laboratories, Inc.	accessdata.fda.gov

Compare with other makers

Updated November 24, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.