FDA 510(k) Applications Submitted by GC America, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K072425 |
08/29/2007 |
JNE IMPLANT SYSTEM |
GC AMERICA, INC. |
| K103234 |
11/02/2010 |
GC AADVA BO AC ABUTMENTS |
GC AMERICA, INC. |
| K093749 |
12/07/2009 |
GC AADVA IMPLANT SYSTEM |
GC AMERICA, INC. |
| K113816 |
12/27/2011 |
GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV |
GC AMERICA, INC. |
| K143140 |
11/03/2014 |
G-Premio BOND |
GC AMERICA, INC. |
| K072100 |
07/31/2007 |
GC AADVA ABUTMENT |
GC AMERICA, INC. |
| K120521 |
02/21/2012 |
GC BLUE SILICONE |
GC AMERICA, INC. |
| K080478 |
02/22/2008 |
GRADIA FORTE |
GC AMERICA, INC. |
| K080724 |
03/14/2008 |
GC OPB-100 |
GC AMERICA, INC. |
| K090747 |
03/20/2009 |
MI FLOW (GCUC-450) |
GC AMERICA, INC. |
| K110871 |
03/29/2011 |
FIT CHECKER ADVANCED |
GC AMERICA, INC. |
| K091106 |
04/16/2009 |
EQUIA |
GC AMERICA, INC. |
| K091388 |
05/11/2009 |
GCUC-505 |
GC AMERICA, INC. |
| K101346 |
05/13/2010 |
GC ORAL MOISTURIZING GEL |
GC AMERICA, INC. |
| K101420 |
05/20/2010 |
GC FUJI TEMP |
GC AMERICA, INC. |
| K141562 |
06/12/2014 |
MSN-006 |
GC AMERICA, INC. |
| K082434 |
08/25/2008 |
GDLS-200 |
GC AMERICA, INC. |
| K082740 |
09/18/2008 |
GC AADVA ZR DISK |
GC AMERICA, INC. |
| K192597 |
09/20/2019 |
Cytrans Granules |
GC America, Inc. |
| K082768 |
09/22/2008 |
G-BOND PLUS |
GC AMERICA, INC. |
| K133182 |
10/17/2013 |
HTFX-222 |
GC AMERICA, INC. |
| K073106 |
11/02/2007 |
UNIFAST III |
GC AMERICA, INC. |
| K153231 |
11/09/2015 |
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer |
GC AMERICA, INC. |
| K153253 |
11/10/2015 |
GC Reline II |
GC AMERICA, INC. |
| K073283 |
11/21/2007 |
GC GAM-100 |
GC AMERICA, INC. |
| K123631 |
11/23/2012 |
MFP-051 |
GC AMERICA, INC. |
| K133824 |
12/17/2013 |
CERASMART |
GC AMERICA, INC. |
| K073588 |
12/20/2007 |
GC MODELS OPA-100 AND JC-50 |
GC AMERICA, INC. |
| K050059 |
01/11/2005 |
G-LIGHT |
GC AMERICA, INC. |
| K042348 |
08/30/2004 |
GRADIA DIRECT LOFLO |
GC AMERICA, INC. |
| K043301 |
11/30/2004 |
GC TION GINGIVAL PROTECTOR |
GC AMERICA, INC. |
| K043493 |
12/17/2004 |
FUSION PUTTY TYPE |
GC AMERICA, INC. |
| K020117 |
01/14/2002 |
GC FUJI LINING LC PASTE PAK |
GC AMERICA, INC. |
| K020342 |
02/01/2002 |
UNIFIL FLOW |
GC AMERICA, INC. |
| K970656 |
02/21/1997 |
HYDROFLEX |
GC AMERICA, INC. |
| K020578 |
02/21/2002 |
GC FUJI ORTHO BAND PASTE PAK |
GC AMERICA, INC. |
| K980695 |
02/23/1998 |
FUJI I |
GC AMERICA, INC. |
| K980682 |
02/23/1998 |
FUJI II |
GC AMERICA, INC. |
| K040567 |
03/04/2004 |
GC INITIAL MC, AL AND LF |
GC AMERICA, INC. |
| K990736 |
03/05/1999 |
GC RELINE SOFT/EXTRA SOFT |
GC AMERICA, INC. |
| K021038 |
04/01/2002 |
GC ELITE CEMENT 100 |
GC AMERICA, INC. |
| K981370 |
04/15/1998 |
MIRACLE MIX CAPSULE |
GC AMERICA, INC. |
| K961448 |
04/16/1996 |
FUJI IX GP |
GC AMERICA, INC. |
| K981461 |
04/23/1998 |
GC FUJI ORTHO LC |
GC AMERICA, INC. |
| K981514 |
04/28/1998 |
GC FUJI BOND LC |
GC AMERICA, INC. |
| K001518 |
05/16/2000 |
GRADIA |
GC AMERICA, INC. |
| K051358 |
05/24/2005 |
NATURE-CRYL HI PLUS |
GC AMERICA, INC. |
| K991774 |
05/25/1999 |
ACRON MC MODIFICATION |
GC AMERICA, INC. |
| K041398 |
05/26/2004 |
GC FUSION |
GC AMERICA, INC. |
| K051427 |
06/01/2005 |
GC FUJI FIL LC |
GC AMERICA, INC. |
| K001730 |
06/07/2000 |
GC FUJICEM |
GC AMERICA, INC. |
| K001823 |
06/16/2000 |
LINKMAX |
GC AMERICA, INC. |
| K012134 |
07/09/2001 |
GC E-LIGHT |
GC AMERICA, INC. |
| K972594 |
07/11/1997 |
METALPRIMER II |
GC AMERICA, INC. |
| K032289 |
07/24/2003 |
FIT CHECKER II |
GC AMERICA, INC. |
| K022430 |
07/25/2002 |
ISO FUNCTIONAL |
GC AMERICA, INC. |
| K982695 |
08/03/1998 |
GC RELINE |
GC AMERICA, INC. |
| K012542 |
08/07/2001 |
REVOTEK LC |
GC AMERICA, INC. |
| K963144 |
08/13/1996 |
GC BASELINE |
GC AMERICA, INC. |
| K042200 |
08/13/2004 |
MI PASTE |
GC AMERICA, INC. |
| K973343 |
09/05/1997 |
HYDROFLEX |
GC AMERICA, INC. |
| K013198 |
09/25/2001 |
FUJI VII CAPSULE |
GC AMERICA, INC. |
| K023727 |
11/06/2002 |
TEMPORARY CEMENT-DC010002 |
GC AMERICA, INC. |
| K023751 |
11/08/2002 |
EXAJET |
GC AMERICA, INC. |
| K023814 |
11/15/2002 |
GRADIA DIRECT |
GC AMERICA, INC. |
| K993973 |
11/23/1999 |
FUJI II LC CAPSULE |
GC AMERICA, INC. |
| K994077 |
12/02/1999 |
AROMA FINE (NORMAL AND FAST SET) |
GC AMERICA, INC. |
| K013997 |
12/04/2001 |
UNIFIL BOND |
GC AMERICA, INC. |
| K984365 |
12/07/1998 |
GC UNIFAST TRAD |
GC AMERICA, INC. |
| K033808 |
12/08/2003 |
GRADIA GUM |
GC AMERICA, INC. |
| K003817 |
12/11/2000 |
PATTERN RESIN |
GC AMERICA, INC. |
| K043471 |
12/16/2004 |
FUSION FAST |
GC AMERICA, INC. |
| K984505 |
12/18/1998 |
MIRACLE MIX POWDER/LIQUID |
GC AMERICA, INC. |
| K070319 |
02/02/2007 |
GC FUJI IX GP EXTRA |
GC AMERICA, INC. |
| K070698 |
03/13/2007 |
COE COMFORT |
GC AMERICA, INC. |
| K070697 |
03/13/2007 |
COE SOFT |
GC AMERICA, INC. |
| K070840 |
03/27/2007 |
GVC-100 |
GC AMERICA, INC. |
| K070854 |
03/28/2007 |
GC MI PASTE PLUS |
GC AMERICA, INC. |
| K061535 |
06/02/2006 |
GC XLC-100 CAPSULE |
GC AMERICA, INC. |
| K071674 |
06/19/2007 |
GC-ZIRCONIA |
GC AMERICA, INC. |
| K052462 |
09/08/2005 |
G-COAT |
GC AMERICA, INC. |
| K961417 |
04/12/1996 |
GC FUJI ORTHO |
GC AMERICA, INC. |
| K961584 |
04/24/1996 |
FUJI II LC (IMPROVED) |
GC AMERICA, INC. |
| K955932 |
12/13/1995 |
EXAFLEX IMPRESSION MATERIAL (MODIFICATION) |
GC AMERICA, INC. |
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