Medical Device Manufacturer · US , Alsip , IL

GC America, Inc.

125 submissions · 125 cleared · Since 1993
125
Total
125
Cleared
0
Denied

GC America, Inc. — FDA 510(k) Submissions

GC America, Inc. has submitted 125 FDA 510(k) premarket notifications since 1993, of which 125 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Cement, Dental, Material, Tooth Shade, Resin, Material, Impression, Resin, Denture, Relining, Repairing, Rebasing, Agent, Tooth Bonding, Resin . Use the specialty filter in the sidebar to narrow results.

125 devices
1–25 of 125
G-Bond Universal
K251124 · KLE Agent, Tooth Bonding, Resin · Dental
Oct 2025 174d
EQUIA LC ONE
K250953 · EMA Cement, Dental · Dental
Sep 2025 175d
G aenial Universal Injectable II
K251946 · EBF Material, Tooth Shade, Resin · Dental
Aug 2025 65d
G-CEM ONE
K200798 · EMA Cement, Dental · Dental
Nov 2020 243d
BZF-29
K200682 · KLE Agent, Tooth Bonding, Resin · Dental
Oct 2020 200d
Cytrans Granules
K192597 · LYC Bone Grafting Material,... · Dental
Aug 2020 332d
GC Temp Print
K193113 · EBG Crown And Bridge,... · Dental
Jul 2020 240d
GC Fuji Triage EP
K193484 · EMA Cement, Dental · Dental
Jul 2020 198d
everX Flow
K192260 · EBF Material, Tooth Shade, Resin · Dental
Nov 2019 93d
GC FujiCEM 2 (Improved)
K182854 · EMA Cement, Dental · Dental
Jul 2019 274d
GC Acrylic Primer
K180917 · KLE Agent, Tooth Bonding, Resin · Dental
Nov 2018 225d
AIM2
K181011 · ELW Material, Impression · Dental
Jul 2018 86d
GC Fuji Direct
K172382 · EMA Cement, Dental · Dental
Apr 2018 237d
NMF004A
K173500 · EBF Material, Tooth Shade, Resin · Dental
Mar 2018 115d
Initial LiSi Block
K153130 · EIH Powder, Porcelain · Dental
Sep 2016 319d
Gradia Plus
K153325 · EBF Material, Tooth Shade, Resin · Dental
Jul 2016 236d
G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer
K153231 · EMA Cement, Dental · Dental
Jul 2016 240d
Initial LiSi Press
K153136 · EIH Powder, Porcelain · Dental
Jun 2016 244d
everX Posterior
K153127 · EBF Material, Tooth Shade, Resin · Dental
May 2016 204d
MSCB-001
K152274 · EIH Powder, Porcelain · Dental
Mar 2016 226d
GC Reline II
K153253 · EBI Resin, Denture, Relining,... · Dental
Mar 2016 114d
G-Fix
K151541 · EBF Material, Tooth Shade, Resin · Dental
Oct 2015 123d
G-Premio BOND
K143140 · KLE Agent, Tooth Bonding, Resin · Dental
Apr 2015 168d
MSN-006
K141562 · EBG Crown And Bridge,... · Dental
Sep 2014 85d
HTFX-222
K133182 · EBF Material, Tooth Shade, Resin · Dental
Apr 2014 174d

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