GC AMERICA INC.

Matched from indexed company URL: GC AMERICA, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1410097	1410097	GC AMERICA INC.	1	Y	2026-01-01	3737 W 127th St ALSIP IL US 60803

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
14550565002269	Cytrans Granules - Cytrans Granules L 0.5g 1pc	+1(708)597-0900	customerservice@gcamerica.com
14550565002276	Cytrans Granules - Cytrans Granules L 2.0g 1pc	+1(708)597-0900	customerservice@gcamerica.com
D047014615	Cytrans Granules - Cytrans Granules L 0.5g 1pc	+1(708)597-0900	customerservice@gcamerica.com
D047014616	Cytrans Granules - Cytrans Granules L 2.0g 1pc	+1(708)597-0900	customerservice@gcamerica.com

gcamerica.com

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
10508	1680795137	K991774	ACRON MC MODIFICATION	EBI	1999-07-09
10508	1286663638	K984365	GC UNIFAST TRAD	EBI	1999-02-25
10508	1488625374	K982695	GC RELINE	EBI	1998-10-19
10508	1213256758	K981461	GC FUJI ORTHO LC	DYH	1998-06-25
10508	1891109837	K970495	FOUNDATION INDIRECT COMPOSITE RESIN	EBF	1997-04-16
10508	1537099194	K963144	GC BASELINE	EBI	1996-10-29
10508	1713777381	K955932	EXAFLEX IMPRESSION MATERIAL (MODIFICATION)	ELW	1996-03-11
10508	1897137165	K953476	MULTI-PRIME AKA/MONO-PRIME	KLE	1995-09-22
10508	1089599276	K951555	FUJI IX	EMA	1995-05-23
10508	1690780030	K950556	FUJI ORTHO LC	DYH	1995-03-08
10508	1321255770	K946100	FUJI DUET	EMA	1995-01-20
10508	1637723563	K942670	GC PATTERN RESIN	EBG	1994-10-18
10508	1959023912	K935261	KOOLINER II	EBI	1994-01-26
10508	1349986232	K933206	EXA BITE REGISTRATION MATERIAL	ELW	1993-09-29
10508	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
10508	1107687347	K904135	FOUNDATION HYBRID COMPOSITE	EBD	1991-05-15
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
10508	1213567481	K881422	COE PAK AUTO MIX, REGULAR OR HARD SET	EMA	1988-10-31
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
10508	1889143392	K812406	EXAFLEX IMPRESSION MATERIAL	ELW	1981-10-06
10508	1213986928	K792427	PERMA-CRYL 20	EBI	1979-12-13
10508	1173032387	K200798	G-CEM ONE	EMA	2020-11-24
10508	1268418619	K200682	BZF-29	KLE	2020-10-02
10508	1211401862	K193484	GC Fuji Triage EP	EMA	2020-07-02
10508	1696103459	K193113	GC Temp Print	EBG	2020-07-09
10508	1827597293	K192597	Cytrans Granules	LYC	2020-08-17
10508	1000743267	K192576
10508	1641837953	K192260	everX Flow	EBF	2019-11-22
10508	1330170294	K182854	GC FujiCEM 2 (Improved)	EMA	2019-07-11
10508	1188774795	K181011	AIM2	ELW	2018-07-12
10508	1396586234	K180917	GC Acrylic Primer	KLE	2018-11-20
10508	2045613613	K173500	NMF004A	EBF	2018-03-08
10508	1505647314	K172382	GC Fuji Direct	EMA	2018-04-02
10508	1114083397	K161025	priti multidisc ZrO2 High Translucent	EIH	2017-02-03
10508	1090759893	K153325	Gradia Plus	EBF	2016-07-12
10508	1222817109	K153253	GC Reline II	EBI	2016-03-03
10508	1972034561	K153231	G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer	EMA	2016-07-06
10508	1751355684	K153136	Initial LiSi Press	EIH	2016-06-30
10508	1856366608	K153130	Initial LiSi Block	EIH	2016-09-13
10508	1531829279	K153127	everX Posterior	EBF	2016-05-20
10508	1553971334	K152274	MSCB-001	EIH	2016-03-25
10508	1203976012	K151541	G-Fix	EBF	2015-10-09
10508	1562458949	K143140	G-Premio BOND	KLE	2015-04-20
10508	1083620844	K141562	MSN-006	EBG	2014-09-05
10508	1113662058	K133836	OPTIGLAZE COLOR	EBD	2014-03-06
10508	1023258461	K133824	CERASMART	EBF	2014-03-14
10508	1239577889	K133182	HTFX-222	EBF	2014-04-09
10508	1990352940	K123631	MFP-051	EBF	2013-07-23
10508	1806894986	K120243	GAM-200	EMA	2012-06-27
10508	1767939426	K111709	FOUNDATION DENTAL RESIN	EBI	2011-11-18
10508	1107056042	K111087	FOUNDATION	LYC	2011-11-29
10508	1249089107	K102808	MI VARNISH	LBH	2010-12-22
10508	1154332452	K101346	GC ORAL MOISTURIZING GEL	LFD	2011-01-27
10508	1833605978	K093751	CL-DC20, CL-DC21	EBZ	2010-02-24
10508	1073736552	K093749	GC AADVA IMPLANT SYSTEM	DZE	2010-12-06
10508	1625064999	K092951	STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS	EBZ	2009-12-07
10508	1870320511	K091388	GCUC-505	EBF	2009-07-22
10508	1459733987	K091106	EQUIA	EMA	2009-06-17
10508	1658760166	K090747	MI FLOW (GCUC-450)	EBF	2009-06-10
10508	1193304130	K082768	G-BOND PLUS	KLE	2008-10-21
10508	1629358450	K082740	GC AADVA ZR DISK	EIH	2008-11-26
10508	1180689384	K082434	GDLS-200	EBF	2008-11-14
10508	1868762604	K080724	GC OPB-100	DYH	2008-06-11
10508	1159366086	K073588	GC MODELS OPA-100 AND JC-50	DYH	2008-02-15
10508	2040562927	K073283	GC GAM-100	EMA	2008-02-20
10508	1268353494	K073106	UNIFAST III	EBG	2008-04-11
10508	1297939778	K070854	GC MI PASTE PLUS	EJR	2007-04-12
10508	1845995418	K070698	COE COMFORT	EBI	2007-03-29
10508	1509437298	K070697	COE SOFT	EBI	2007-03-29
10508	1738921086	K061535	GC XLC-100 CAPSULE	EMA	2006-07-14
10508	1861707903	K052462	G-COAT	EBD	2005-10-20
10508	1416096015	K051427	GC FUJI FIL LC	EMA	2005-08-22
10508	1126805416	K051358	NATURE-CRYL HI PLUS	EBI	2005-07-07
10508	1710231285	K043493	FUSION PUTTY TYPE	ELW	2005-03-04
10508	1020170014	K043471	FUSION FAST	ELW	2005-01-27
10508	1875357800	K043301	GC TION GINGIVAL PROTECTOR	EIE	2005-01-25
10508	1153807389	K042200	MI PASTE	EJR	2004-10-20
10508	1617386673	K041471	G-BOND	KLE	2004-06-29
10508	1367261191	K041398	GC FUSION	ELW	2004-06-25
10508	1867198589	K040783	FOUNDATION	LYC	2004-10-13
10508	1489105514	K040567	GC INITIAL MC, AL AND LF	EIH	2004-04-22
10508	1923686745	K032289	FIT CHECKER II	ELW	2003-10-20
10508	1361597252	K031341	STICK FLOW	EBF	2003-10-29
10508	1487555442	K030072	EVERSTICK PERIO	EBI	2003-04-10
10508	1260899603	K023814	GRADIA DIRECT	EBF	2003-01-30
10508	1960699939	K023751	EXAJET	ELW	2003-01-22
10508	1933439953	K023727	TEMPORARY CEMENT-DC010002	EMA	2003-01-16
10508	1614981184	K022430	ISO FUNCTIONAL	ELW	2002-10-18
10508	2003672530	K021126	EVERSTICK ORTHO	EBI	2002-05-13
10508	1727003587	K020578	GC FUJI ORTHO BAND PASTE PAK	DYH	2002-04-26
10508	1937249405	K020342	UNIFIL FLOW	EBF	2002-03-28
10508	2022794214	K020117	GC FUJI LINING LC PASTE PAK	EMA	2002-02-28
10508	1479278936	K013198	FUJI VII CAPSULE	EMA	2001-10-29
10508	1779505767	K012542	REVOTEK LC	EBC	2001-10-16
10508	1167171228	K011799	EVERSTICKNET	EBI	2001-11-05
10508	1809924935	K011788	EVERSTICK	EBI	2001-11-05
10508	1025169334	K003817	PATTERN RESIN	EBG	2001-01-16
10508	1346051775	K003334	STICK NET	EBI	2001-01-08
10508	1086738452	K003333	STICK	EBI	2001-01-04
10508	1240189311	K001823	LINKMAX	EMA	2000-08-16
10508	1713833449	K001518	GRADIA	EBF	2000-07-05
10508	1004324219
10508	1040219674
10508	1062334562
10508	1065049139
10508	1066176493
10508	1243402040
10508	1263369882
10508	1281315253
10508	1290781303
10508	1296442718
10508	1372611134

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
EBI	18	2016-03-03
EMA	17	2020-11-24
EBF	16	2019-11-22
ELW	14	2018-07-12
EBG	7	2020-07-09
EIH	7	2017-02-03
KLE	6	2020-10-02
DYH	5	2008-06-11
LYC	3	2020-08-17
EBD	3	2014-03-06
EBZ	2	2010-02-24
EJR	2	2007-04-12
MED	2	1994-12-06
LFD	1	2011-01-27
LBH	1	2010-12-22
DZE	1	2010-12-06
EIE	1	2005-01-25
EBC	1	2001-10-16
EID	1	1981-10-06

NDC#

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

PMN#

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.

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.

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.

G-Premio BOND

2015-04-20

GC AMERICA, INC.

MSN-006

2014-09-05

GC AMERICA, INC.

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.

GC FUJI TEMP

2010-09-17

GC AMERICA, INC.

AADVA ZR COLORING LIQUID

2009-09-29

GC AMERICA INC.

GCUC-505

2009-07-22

GC AMERICA, INC.

EQUIA

2009-06-17

GC AMERICA, INC.

MI FLOW (GCUC-450)

2009-06-10

GC AMERICA, INC.

GC AADVA ZR DISK

2008-11-26

GC AMERICA, INC.

GDLS-200

2008-11-14

GC AMERICA, INC.

121 records. Showing 1-40. Next

GUDID#

Cytrans Granules - Cytrans Granules L 0.5g 1pc

Gc America Inc.

2026-03-03

Cytrans Granules - Cytrans Granules L 2.0g 1pc

Gc America Inc.

2026-03-03

Cytrans Granules - Cytrans Granules L 0.5g 1pc

Gc America Inc.

2026-03-03

Cytrans Granules - Cytrans Granules L 2.0g 1pc

Gc America Inc.

2026-03-03

GC Fuji ORTHO™ - GC Fuji ORTHO™ Intro Package, 1-2 Pack (1 x 40g powder, 2 x 6.8mL liquid & accessories)

Gc America Inc.

2016-08-01

EXAFLEX® - EXAFLEX® Base (One pail 30kg)

Gc America Inc.

2016-08-01

GC Fuji ORTHO™ - GC Fuji ORTHO™ Band (Paste Pak) Starter Package (2 x 13.3 g (7.2mL) cartridges, 1 x mixing pad, 1 x GC Paste Pak Dispenser & 1 x GC Fuji SPATULA)

Gc America Inc.

2016-08-01

GC Fuji ORTHO™ - GC Fuji ORTHO™ LC Starter Package (50 x capsules - (mixed volume per capsule 0.10mL), 1 x GC ORTHO CONDITIONER, 1 x Capsule Applier)

Gc America Inc.

2016-08-01

GC Fuji ORTHO™ - GC Fuji ORTHO™ LC Box of 50 capsules (mixed volume per capsule 0.10mL)

Gc America Inc.

2016-08-01

GC Fuji ORTHO™ - GC Fuji ORTHO™ LC Standard Package (1 x 40g powder, 2 x 6.8mL liquid, 1 x scoop & 1 x mixing pad)

Gc America Inc.

2016-08-01

GC Fuji ORTHO™ - GC Fuji ORTHO™ LC Introductory Package (1 x 15g powder, 1 x 6.8mL liquid, 1 x scoop & 1 x mixing pad)

Gc America Inc.

2016-08-01

GC Fuji TEMP LT™ - GC Fuji TEMP LT™ Introductory Kit (2 x Paste Pak Cartridge 13.3g (7.2mL), 1 x mixing pad & 1 x GC Paste Pak Dispenser)

Gc America Inc.

2016-08-01

Miracle Mix® - Miracle Mix® (100 x tube and 100 x plug)

Gc America Inc.

2016-08-01

GC Fuji LINING™ - GC Fuji LINING™LC (Paste Pak) Starter Package (1 x 7g (7.2mL) Cartridge, 1 x GC Paste Pak Dispenser, 1 x mixing pad, 1 x spatula)

Gc America Inc.

2016-08-01

GC Fuji PLUS® - GC Fuji PLUS® No Etch Package (1 x 15g powder, 1 x 7mL liquid & accessories)

Gc America Inc.

2016-08-01

GC Fuji PLUS® - GC Fuji PLUS® 7mL liquid

Gc America Inc.

2016-08-01

GC Fuji PLUS® - GC Fuji PLUS® 15g powder

Gc America Inc.

2016-08-01

GC Fuji PLUS® - GC Fuji PLUS® 1:1 Kit (1 x 15g powder, 1 x 7mL liquid, 1 x GC Fuji PLUS CONDITIONER & accessories)

Gc America Inc.

2016-08-01

GC Fuji I® - GC Fuji I® Capsules (48)

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® Capsule (48) Assorted Starter (10 each of A2, A3, A3.5, 9 each of B2 & B3, Capsule Applier, Cavity Conditioner, and Fuji COAT LC)

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® Capsule (48)- B3

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® Capsule (48)- B2

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® Capsule (48)- A3.5

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® Capsule (48)- A3

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® Capsule (48)- A2

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® Capsule (48) Assorted (10 each of A2, A3, A3.5, 9 each of B2 & B3)

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® FAST Capsule (48) Assorted Starter (10 each of A2, A3, A3.5, 9 each of B2 & B3, Capsule Applier, Cavity Conditioner, and Fuji COAT LC)

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® FAST Capsule (48)-A1

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® FAST Capsule (48)- B3

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® FAST Capsule (48)- B2

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® FAST Capsule (48)- A3.5

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® FAST Capsule (48)- A3

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® FAST Capsule (48)- A2

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® FAST Capsule (48) Assorted (10 each of A2, A3, A3.5, 9 each of B2 & B3)

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® EXTRA Capsule (48) Assorted Starter (10 each of A2, A3,A3.5, 9 each of B1 & B3, Capsule Applier, Cavity Conditioner, and Fuji COAT LC)

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® EXTRA Capsule (48) - C4

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® EXTRA Capsule (48) - B3

Gc America Inc.

2016-08-01

GC Fuji IX GP® - GC Fuji IX GP® EXTRA Capsule (48) - B2

Gc America Inc.

2016-08-01

TEMPSMART™ - TEMPSMART™ 48mL Mixing Tip II SSS (20)

Gc America Inc.

2016-08-01

NATURE-CRYL® - NATURE-CRYL® SUPER HI IMPACT LIGHT REDDISH PINK 1lb POWDER

Gc America Inc.

2016-08-01

80 records. Showing 1-40. Next