GC Manufacturing America LLC

Matched from indexed company URL: GC CORP.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
		GC Manufacturing America LLC	5	Y	2026-01-01	3737 W 127th St Alsip IL US 60803
1410097	1410097	GC AMERICA INC.	1	Y	2026-01-01	3737 W 127th St ALSIP IL US 60803
9613953	3002807052	GC DENTAL PRODUCTS CORP.	1	N	2026-01-01	2-285 TORIIMATSU-CHO KASUGAI-SHI Aichi JP 486-0844
3002807050	3002807050	GC CORPORATION-FUJI OYAMA FACTORY	1	N	2026-01-01	584-1 NAKAHINATA OYAMA-CHO SUNTO-GUN, Shizuoka-Ken JP 410-1307
3003775534	3003775534	GC EUROPE N.V.	1	N	2026-01-01	Researchpark Haasrode - Leuven 1240 Interleuvenlaan 33 LEUVEN Vlaams Brabant BE 3001
3004146043	3004146043	GC ASAHI CORPORATION	1	N	2026-01-01	1-3-3 KACHIGAWA-CHO KASUGAI-SHI AICHI JP --
3006128321	3006128321	GCX Corporation	1	N	2026-01-01	26 Spur Dr El Paso TX US 79906
3007681502	3007681502	GCMEDICA ENTERPRISE LTD. (WUXI)	1	N	2026-01-01	Loujin Industrial Park,Shuofang Wuxi Jiangsu CN 214143
3008186372	3008186372	GCDL, LLC	1	Y	2026-01-01	4 E. Piper Lane Suite J Prospect Heights IL US 60070
3008363441	3008363441	GCX CORPORATION	1	N	2026-01-01	3875 Cypress Drive Petaluma CA US 94954
3010032042	3010032042	GC Orthodontics America Inc.	1	Y	2026-01-01	3737 W. 127th Street Alsip IL US 60803
3013259506	3013259506	GCOOP USA CORP.	1	Y	2026-01-01	6710 Wilson Ave ROOM A Los Angeles CA US 90001
3016575453	3016575453	GCE INTERNATIONAL INC	1	Y	2026-01-01	1385 Broadway New York NY US 10018
3027241817	3027241817	GC Dental Mexicana, S.A. de C.V.	1	N	2026-01-01	22a Avenida No. 233 Cumbres Monterrey Nuevo Leon MX 64610
3027555943	3027555943	GC Corporation Mishima Factory	1	N	2026-01-01	454-1 Higashino Nagaizumi-Cho Sunto-Gun Shizuoka JP 411-0931
3030419987	3030419987	GCB MEDICAL LLC	1	Y	2026-01-01	25 Depot St Duxbury MA US 02332
3045816931	3045816931	GC America Inc.	1	N	2026-01-01	Carretera Federal 45, Irapuato-Silao KM 144 + 300 Parque Industr Int 26, 27, 33 Ejido de Vallejos Guanajuato Mexico MX 36293
3010259872	3010259872	GC Orthodontics Europe GmbH	1	N	2020-04-25	Harkortstrasse 2 Breckerfeld Nordrhein-Westfalen DE 58339
3012191715	3012191715	GCCT ASSETS LLC	1	Y	2020-04-25	1001 SWITHLAND CT Raleigh NC US 27614
3013757744	3013757744	GCE GAS CONTROL EQUIPMENT INC.	1	N	2020-04-25	1508 Windsor Forest Trail Keller TX US 76262
3015152462	3015152462	GCL SYSTEMS, INC.	1	N	2020-04-25	1172 West 700 North Suite 210 Lindon UT US 84042

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
10508	1781956869	K994077	AROMA FINE (NORMAL AND FAST SET)	ELW	2000-01-27
10516	1781956869	K994077	AROMA FINE (NORMAL AND FAST SET)	ELW	2000-01-27
10516	1789645005	K993973	FUJI II LC CAPSULE	EBF	2000-01-11
316544	1789645005	K993973	FUJI II LC CAPSULE	EBF	2000-01-11
350667	1789645005	K993973	FUJI II LC CAPSULE	EBF	2000-01-11
351436	1789645005	K993973	FUJI II LC CAPSULE	EBF	2000-01-11
10508	1680795137	K991774	ACRON MC MODIFICATION	EBI	1999-07-09
10509	1680795137	K991774	ACRON MC MODIFICATION	EBI	1999-07-09
10509	1202442741	K990736	GC RELINE SOFT/EXTRA SOFT	EBI	1999-05-28
10516	1303215087	K984505	MIRACLE MIX POWDER/LIQUID	EMA	1999-02-04
351436	1303215087	K984505	MIRACLE MIX POWDER/LIQUID	EMA	1999-02-04
10508	1286663638	K984365	GC UNIFAST TRAD	EBI	1999-02-25
10509	1286663638	K984365	GC UNIFAST TRAD	EBI	1999-02-25
10508	1488625374	K982695	GC RELINE	EBI	1998-10-19
10509	1488625374	K982695	GC RELINE	EBI	1998-10-19
10516	1997229749	K981514	GC FUJI BOND LC	KLE	1998-06-16
10508	1213256758	K981461	GC FUJI ORTHO LC	DYH	1998-06-25
10516	1213256758	K981461	GC FUJI ORTHO LC	DYH	1998-06-25
10516	1127825682	K981370	MIRACLE MIX CAPSULE	EMA	1998-06-01
316544	1127825682	K981370	MIRACLE MIX CAPSULE	EMA	1998-06-01
10510	1382721893	K980695	FUJI I	EMA	1998-04-13
10516	1382721893	K980695	FUJI I	EMA	1998-04-13
316544	1382721893	K980695	FUJI I	EMA	1998-04-13
10516	1656034756	K980682	FUJI II	EMA	1998-04-03
10509	1278722287	K972594	METALPRIMER II	KLE	1997-08-26
10508	1891109837	K970495	FOUNDATION INDIRECT COMPOSITE RESIN	EBF	1997-04-16
10508	1537099194	K963144	GC BASELINE	EBI	1996-10-29
10509	1537099194	K963144	GC BASELINE	EBI	1996-10-29
10516	1433867205	K961584	FUJI II LC (IMPROVED)	EMA	1996-05-24
10516	1194937158	K961448	FUJI IX GP	EMA	1996-07-08
316544	1194937158	K961448	FUJI IX GP	EMA	1996-07-08
350667	1194937158	K961448	FUJI IX GP	EMA	1996-07-08
351436	1194937158	K961448	FUJI IX GP	EMA	1996-07-08
10516	1024236619	K961417	GC FUJI ORTHO	DYH	1996-05-24
10508	1713777381	K955932	EXAFLEX IMPRESSION MATERIAL (MODIFICATION)	ELW	1996-03-11
10516	1713777381	K955932	EXAFLEX IMPRESSION MATERIAL (MODIFICATION)	ELW	1996-03-11
10508	1897137165	K953476	MULTI-PRIME AKA/MONO-PRIME	KLE	1995-09-22
10516	1246884777	K953166	FUJI BOND LC	KLE	1995-09-27
10508	1089599276	K951555	FUJI IX	EMA	1995-05-23
10514	1089599276	K951555	FUJI IX	EMA	1995-05-23
10516	1089599276	K951555	FUJI IX	EMA	1995-05-23
10508	1690780030	K950556	FUJI ORTHO LC	DYH	1995-03-08
10516	1690780030	K950556	FUJI ORTHO LC	DYH	1995-03-08
316544	1690780030	K950556	FUJI ORTHO LC	DYH	1995-03-08
10508	1321255770	K946100	FUJI DUET	EMA	1995-01-20
10510	1321255770	K946100	FUJI DUET	EMA	1995-01-20
10516	1321255770	K946100	FUJI DUET	EMA	1995-01-20
316544	1321255770	K946100	FUJI DUET	EMA	1995-01-20
10508	1637723563	K942670	GC PATTERN RESIN	EBG	1994-10-18
10516	1432526864	K935961	GC FUJI COAT LC	KLE	1994-03-10
10508	1959023912	K935261	KOOLINER II	EBI	1994-01-26
10508	1349986232	K933206	EXA BITE REGISTRATION MATERIAL	ELW	1993-09-29
10509	1349986232	K933206	EXA BITE REGISTRATION MATERIAL	ELW	1993-09-29
10516	1349986232	K933206	EXA BITE REGISTRATION MATERIAL	ELW	1993-09-29
10508	1310819142	K932039	G-CERA ORBIT COLOUR COMMUNICATION SET	EIH	1993-07-08
10509	1310819142	K932039	G-CERA ORBIT COLOUR COMMUNICATION SET	EIH	1993-07-08
10508	1394060980	K931592	METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE	MED	1994-12-06
10508	1807724942	K931052	METRICIDE 28	MED	1994-12-06
10516	1946364945	K913884	FUJI II LC	EMA	1991-10-30
10508	1107687347	K904135	FOUNDATION HYBRID COMPOSITE	EBD	1991-05-15
10516	1608812640	K901999	FUJI LINING CEMENT LIGHT CURE	EJK	1990-07-31
10508	1885875142	K894282	FIRST IMPRESSION TM	ELW	1989-12-22
10508	1443061832	K894281	FIRST IMPRESSION WITH CHLORHEXIDINE	ELW	1989-09-26
10508	1432950158	K890829	UNIFAST LC	EBG	1989-04-17
10509	1432950158	K890829	UNIFAST LC	EBG	1989-04-17
10508	1213567481	K881422	COE PAK AUTO MIX, REGULAR OR HARD SET	EMA	1988-10-31
10516	1393052506	K880848	FUJI CAP II CAPSULE & APPLIER	EMA	1988-05-16
316544	1393052506	K880848	FUJI CAP II CAPSULE & APPLIER	EMA	1988-05-16
10516	1501003575	K851469	76 ELW BITE CHECKER SILICONE	ELW	1985-05-01
10516	1683055032	K851468	76 EMA LINING CEMENT	EMA	1985-05-01
10509	1235474806	K842994	EMA FREEGENOL DENTAL CEMENT	EMA	1984-10-18
10516	1235474806	K842994	EMA FREEGENOL DENTAL CEMENT	EMA	1984-10-18
10508	2038780197	K833261	INTERIM TEMP. CROWN & BRIDGE RESIN	EBG	1984-01-03
10508	2040212286	K820673	SELF-CURING HARD DENTURE LINER	EBI	1982-04-09
10508	1453767878	K812680	G-C IMPRESSION SYRINGE	EID	1981-10-06
10508	1736312093	K812679	G-C FIT-CHECKER IMPRESSION MATERIAL	ELW	1981-10-06
10509	1736312093	K812679	G-C FIT-CHECKER IMPRESSION MATERIAL	ELW	1981-10-06
10514	1761640190	K812568	CAVITRON	EMA	1981-09-25
10508	1889143392	K812406	EXAFLEX IMPRESSION MATERIAL	ELW	1981-10-06
10509	1889143392	K812406	EXAFLEX IMPRESSION MATERIAL	ELW	1981-10-06
10508	1213986928	K792427	PERMA-CRYL 20	EBI	1979-12-13
10509	1777912360	K261246	SRGC-06	EBF	2026-06-18
10509	1891347049	K251124	G-Bond Universal	KLE	2025-10-02
325599	1475627717	K222225	Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)	LZA	2022-11-11
325599	1281633419	K222129	Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim	LZA	2023-02-10
325599	1752749316	K220458	UltraFlo-R Push Button Blood Collection Set	JKA	2023-09-29
325599	2023800638	K213177	Plus Medical Cover Gown	FYA	2022-05-11
10508	1173032387	K200798	G-CEM ONE	EMA	2020-11-24
10508	1268418619	K200682	BZF-29	KLE	2020-10-02
10509	1268418619	K200682	BZF-29	KLE	2020-10-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
EMA	90	2020-11-24
EBF	59	2026-06-18
ELW	39	2018-07-12
EBI	27	2016-03-03
KLE	24	2025-10-02
DYH	23	2015-07-16
EIH	21	2017-02-03
EBG	16	2020-07-09
EBD	8	2014-03-06
LBH	4	2010-12-22
EBZ	4	2010-02-24
LZA	3	2023-02-10
LYC	3	2020-08-17
LFD	3	2011-01-27
DZE	3	2010-12-06
EIE	3	2005-01-25
EBC	3	2001-10-16
JKA	2	2023-09-29
NJM	2	2012-12-21
NHA	2	2011-06-30
EJR	2	2007-04-12
MED	2	1994-12-06
EJK	2	1990-07-31
FYA	1	2022-05-11
LHI	1	2019-12-02
CAW	1	2017-05-24
FXX	1	2013-07-17
HIB	1	2008-02-08
MPO	1	2004-05-03
EID	1	1981-10-06

NDC#

Alyglo
GC Biopharma Corp.
Human immunoglobulin G
MIPasteOne Kids Blue Raspberry
GC America Inc.
MI Paste One Kids Blue Raspberry
MIPaste One Kids Bubble Gum
GC America Inc.
MIPaste One Kids Bubble Gum
MIPaste One Kids Cotton Candy
GC America Inc.
MIPaste One Kids Cotton Candy
MIPaste One Kids Blue Raspberry
GC America Inc.
MIPaste One Kids Blue Raspberry
MIPaste One Perio
GC America Inc.
MIPaste One Perio
MIPaste One
GC America Inc.
MIPaste One
MIPaste Plus Strawberry
GC America Inc.
MIPaste Plus Strawberry
MIPaste Plus Mint
GC America Inc.
MIPaste Plus Mint
MIPaste Plus Vanilla
GC America Inc.
MIPaste Plus Vanilla
MIPaste Plus Tutti Frutti
GC America Inc.
MIPaste Plus Tutti Frutti
MIPaste Plus Melon
GC America Inc.
MIPaste Plus Melon
MIPaste Plus Strawberry
GC America Inc.
sodium fluoride
Oxygen
GC Medical Equipment, Inc.
Oxygen

PMN#

Plaxpot Multi Plasma
2023-10-27
Gcs Co. Limited
G-CEM ONE
2020-11-24
GC America Inc.
BZF-29
2020-10-02
GC America Inc.
Cytrans Granules
2020-08-17
GC America, Inc.
GC Temp Print
2020-07-09
GC America Inc.
GC Fuji Triage EP
2020-07-02
GC America Inc.
Decanting Device
2019-12-02
Gcmedica Enterprise Ltd., (WUXI)
EverX Flow
2019-11-22
GC America Inc.
GC FujiCEM 2 (Improved)
2019-07-11
GC America Inc.
GC Acrylic Primer
2018-11-20
GC America Inc.
AIM2
2018-07-12
GC America Inc.
GC Fuji Direct
2018-04-02
GC America Inc.
NMF004A
2018-03-08
GC America Inc.
Focus Cap
2018-01-19
GCE Medical Corporation
Initial LiSi Block
2016-09-13
GC AMERICA INC.
Gradia Plus
2016-07-12
GC America Inc.
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer
2016-07-06
GC AMERICA, INC.
Initial LiSi Press
2016-06-30
GC AMERICA INC.
EverX Posterior
2016-05-20
GC AMERICA INC.
MSCB-001
2016-03-25
GC AMERICA INC.
GC Reline II
2016-03-03
GC AMERICA, INC.
G-Fix
2015-10-09
GC America Inc.
GC Ortho Connect, GC Ortho Etching Gel
2015-07-16
GC Orthodontics America Inc.
E-App
2015-05-20
GC MEDTECH, LLC
GC KommonBase
2015-05-07
GC Orthodontics America Inc.
G-Premio BOND
2015-04-20
GC AMERICA, INC.
MSN-006
2014-09-05
GC AMERICA, INC.
GENTLECARE AR APPLICATOR
2014-04-18
GC MEDTECH, LLC
HTFX-222
2014-04-09
GC AMERICA, INC.
CERASMART
2014-03-14
GC AMERICA, INC.
OPTIGLAZE COLOR
2014-03-06
GC AMERICA INC.
MFP-051
2013-07-23
GC AMERICA, INC.
GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV
2013-01-30
GC AMERICA, INC.
GAM-200
2012-06-27
GC AMERICA INC.
GC BLUE SILICONE
2012-05-10
GC AMERICA, INC.
GC AADVA BO AC ABUTMENTS
2011-06-30
GC AMERICA, INC.
FIT CHECKER ADVANCED
2011-06-17
GC AMERICA, INC.
GC ORAL MOISTURIZING GEL
2011-01-27
GC AMERICA, INC.
MI VARNISH
2010-12-22
GC AMERICA INC.
GC AADVA IMPLANT SYSTEM
2010-12-06
GC AMERICA, INC.

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