Alyglo
Human immunoglobulin G
GC Manufacturing America LLC
FDA Registration(s)#
| 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 |
| 9612300 | 3002808289 | GC CORP. | 1 | N | 2026-01-01 | 76-1 HASUNUMA-CHO ITABASHI-KU Tokyo JP 174-8585 |
| 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 |
| 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 | 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 |
| 10517 | 1781956869 | K994077 | AROMA FINE (NORMAL AND FAST SET) | ELW | 2000-01-27 |
| 10516 | 1789645005 | K993973 | FUJI II LC CAPSULE | EBF | 2000-01-11 |
| 10517 | 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 |
| 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 |
| 10517 | 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 |
| 10517 | 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 |
| 10517 | 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 |
| 10517 | 1213256758 | K981461 | GC FUJI ORTHO LC | DYH | 1998-06-25 |
| 10516 | 1127825682 | K981370 | MIRACLE MIX CAPSULE | EMA | 1998-06-01 |
| 10517 | 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 |
| 10517 | 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 |
| 10517 | 1656034756 | K980682 | FUJI II | EMA | 1998-04-03 |
| 10509 | 1278722287 | K972594 | METALPRIMER II | KLE | 1997-08-26 |
| 10517 | 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 |
| 10517 | 1433867205 | K961584 | FUJI II LC (IMPROVED) | EMA | 1996-05-24 |
| 10516 | 1194937158 | K961448 | FUJI IX GP | EMA | 1996-07-08 |
| 10517 | 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 |
| 10516 | 1024236619 | K961417 | GC FUJI ORTHO | DYH | 1996-05-24 |
| 10517 | 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 |
| 10517 | 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 |
| 10517 | 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 |
| 10517 | 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 |
| 10517 | 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 |
| 10517 | 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 |
| 10517 | 1637723563 | K942670 | GC PATTERN RESIN | EBG | 1994-10-18 |
| 10516 | 1432526864 | K935961 | GC FUJI COAT LC | KLE | 1994-03-10 |
| 10517 | 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 |
| 10517 | 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 |
| 10517 | 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 |
| 10517 | 1608812640 | K901999 | FUJI LINING CEMENT LIGHT CURE | EJK | 1990-07-31 |
| 10508 | 1885875142 | K894282 | FIRST IMPRESSION TM | ELW | 1989-12-22 |
| 10517 | 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 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| EMA | 117 | 2025-09-19 |
| EBF | 70 | 2025-08-29 |
| ELW | 49 | 2018-07-12 |
| KLE | 30 | 2020-10-02 |
| EBI | 29 | 2016-03-03 |
| DYH | 28 | 2015-07-16 |
| EIH | 25 | 2017-02-03 |
| EBG | 19 | 2020-07-09 |
| EBD | 9 | 2014-03-06 |
| DZE | 7 | 2010-12-06 |
| NHA | 6 | 2013-01-30 |
| LYC | 5 | 2020-08-17 |
| LFD | 5 | 2011-01-27 |
| LBH | 5 | 2010-12-22 |
| EBZ | 5 | 2010-02-24 |
| LZA | 3 | 2023-02-10 |
| EIE | 3 | 2005-01-25 |
| EBC | 3 | 2001-10-16 |
| EJK | 3 | 1990-07-31 |
| EID | 3 | 1981-10-06 |
| JKA | 2 | 2023-09-29 |
| NJM | 2 | 2012-12-21 |
| EJR | 2 | 2007-04-12 |
| MED | 2 | 1994-12-06 |
| 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 |
NDC#
MIPasteOne Kids Blue Raspberry
MI Paste One Kids Blue Raspberry
MIPaste One Kids Bubble Gum
MIPaste One Kids Bubble Gum
MIPaste One Kids Cotton Candy
MIPaste One Kids Cotton Candy
MIPaste One Kids Blue Raspberry
MIPaste One Kids Blue Raspberry
MIPaste One Perio
MIPaste One Perio
MIPaste One
MIPaste One
MIPaste Plus Strawberry
MIPaste Plus Strawberry
MIPaste Plus Mint
MIPaste Plus Mint
MIPaste Plus Vanilla
MIPaste Plus Vanilla
MIPaste Plus Tutti Frutti
MIPaste Plus Tutti Frutti
MIPaste Plus Melon
MIPaste Plus Melon
MIPaste Plus Strawberry
sodium fluoride
Oxygen
Oxygen
PMN#
Plaxpot Multi Plasma
Gcs Co. Limited
G-CEM ONE
GC America Inc.
BZF-29
GC America Inc.
Cytrans Granules
GC America, Inc.
GC Temp Print
GC America Inc.
GC Fuji Triage EP
GC America Inc.
Decanting Device
Gcmedica Enterprise Ltd., (WUXI)
EverX Flow
GC America Inc.
GC FujiCEM 2 (Improved)
GC America Inc.
GC Acrylic Primer
GC America Inc.
AIM2
GC America Inc.
GC Fuji Direct
GC America Inc.
NMF004A
GC America Inc.
Focus Cap
GCE Medical Corporation
Initial LiSi Block
GC AMERICA INC.
Gradia Plus
GC America Inc.
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer
GC AMERICA, INC.
Initial LiSi Press
GC AMERICA INC.
EverX Posterior
GC AMERICA INC.
MSCB-001
GC AMERICA INC.
GC Reline II
GC AMERICA, INC.
G-Fix
GC America Inc.
GC Ortho Connect, GC Ortho Etching Gel
GC Orthodontics America Inc.
E-App
GC MEDTECH, LLC
GC KommonBase
GC Orthodontics America Inc.
G-Premio BOND
GC AMERICA, INC.
MSN-006
GC AMERICA, INC.
GENTLECARE AR APPLICATOR
GC MEDTECH, LLC
HTFX-222
GC AMERICA, INC.
CERASMART
GC AMERICA, INC.
OPTIGLAZE COLOR
GC AMERICA INC.
MFP-051
GC AMERICA, INC.
GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV
GC AMERICA, INC.
GAM-200
GC AMERICA INC.
GC BLUE SILICONE
GC AMERICA, INC.
GC AADVA BO AC ABUTMENTS
GC AMERICA, INC.
FIT CHECKER ADVANCED
GC AMERICA, INC.
GC ORAL MOISTURIZING GEL
GC AMERICA, INC.
MI VARNISH
GC AMERICA INC.
GC AADVA IMPLANT SYSTEM
GC AMERICA, INC.