FDA 510(k) Applications Submitted by GC AMERICA INC.

FDA 510(k) Number Submission Date Device Name Applicant
K120243 01/27/2012 GAM-200 GC AMERICA INC.
K200682 03/16/2020 BZF-29 GC America Inc.
K200798 03/26/2020 G-CEM ONE GC America Inc.
K180917 04/09/2018 GC Acrylic Primer GC America Inc.
K181011 04/17/2018 AIM2 GC America Inc.
K151541 06/08/2015 G-Fix GC America Inc.
K092020 07/06/2009 AADVA ZR COLORING LIQUID 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.
K102808 09/28/2010 MI VARNISH GC AMERICA INC.
K182854 10/10/2018 GC FujiCEM 2 (Improved) 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.
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.
K193484 12/17/2019 GC Fuji Triage EP GC America Inc.
K133836 12/18/2013 OPTIGLAZE COLOR GC AMERICA INC.
K041471 06/02/2004 G-BOND GC AMERICA INC.
K070190 01/22/2007 GRADIA DIRECT X GC AMERICA INC.


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