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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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