FDA 510(k) Applications Submitted by MARK HEISS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150128 |
01/20/2015 |
GC Ortho Connect, GC Ortho Etching Gel |
GC Orthodontics America Inc. |
| K120243 |
01/27/2012 |
GAM-200 |
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. |
| K200682 |
03/16/2020 |
BZF-29 |
GC America Inc. |
| K090747 |
03/20/2009 |
MI FLOW (GCUC-450) |
GC AMERICA, INC. |
| K200798 |
03/26/2020 |
G-CEM ONE |
GC America Inc. |
| K110871 |
03/29/2011 |
FIT CHECKER ADVANCED |
GC AMERICA, INC. |
| K180917 |
04/09/2018 |
GC Acrylic Primer |
GC America Inc. |
| K091106 |
04/16/2009 |
EQUIA |
GC AMERICA, INC. |
| K181011 |
04/17/2018 |
AIM2 |
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. |
| K151541 |
06/08/2015 |
G-Fix |
GC America Inc. |
| K141562 |
06/12/2014 |
MSN-006 |
GC AMERICA, INC. |
| K092020 |
07/06/2009 |
AADVA ZR COLORING LIQUID |
GC AMERICA INC. |
| K082171 |
08/01/2008 |
GRADIA CORE |
GC AMERICA, INC |
| K172382 |
08/08/2017 |
GC Fuji Direct |
GC America Inc. |
| K152274 |
08/12/2015 |
MSCB-001 |
GC AMERICA INC. |
| K192260 |
08/21/2019 |
everX Flow |
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. |
| K102808 |
09/28/2010 |
MI VARNISH |
GC AMERICA INC. |
| K182854 |
10/10/2018 |
GC FujiCEM 2 (Improved) |
GC America Inc. |
| K133182 |
10/17/2013 |
HTFX-222 |
GC AMERICA, INC. |
| K153127 |
10/29/2015 |
everX Posterior |
GC AMERICA INC. |
| K153130 |
10/30/2015 |
Initial LiSi Block |
GC AMERICA INC. |
| K153136 |
10/30/2015 |
Initial LiSi Press |
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. |
| K193113 |
11/12/2019 |
GC Temp Print |
GC America Inc. |
| K173500 |
11/13/2017 |
NMF004A |
GC America Inc. |
| K153325 |
11/19/2015 |
Gradia Plus |
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. |
| K193484 |
12/17/2019 |
GC Fuji Triage EP |
GC America Inc. |
| K133836 |
12/18/2013 |
OPTIGLAZE COLOR |
GC AMERICA INC. |
| K073588 |
12/20/2007 |
GC MODELS OPA-100 AND JC-50 |
GC AMERICA, INC. |
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