Medical Device Manufacturer · US , Alsip , IL

GC America, Inc. - FDA 510(k) Cleared Devices

128 submissions · 128 cleared · Since 1993

Recent clearances: Cytrans™ Elashield, SRGC-06, G-CEM UNIVERSAL

128
Total
128
Cleared
0
Denied

FDA 510(k) Regulatory Record - GC America, Inc. Dental ✕

128 devices
1-12 of 128
Cleared Jul 06, 2026
Cytrans™ Elashield
K253317 · LYC
Dental · 279d
Cleared Jun 18, 2026
SRGC-06
K261246 · EBF
Dental · 63d
Cleared May 18, 2026
G-CEM UNIVERSAL
K254109 · EMA
Dental · 150d
Cleared Oct 02, 2025
G-Bond Universal
K251124 · KLE
Dental · 174d
Cleared Sep 19, 2025
EQUIA LC ONE
K250953 · EMA
Dental · 175d
Cleared Aug 29, 2025
G aenial Universal Injectable II
K251946 · EBF
Dental · 65d
Cleared Nov 24, 2020
G-CEM ONE
K200798 · EMA
Dental · 243d
Cleared Oct 02, 2020
BZF-29
K200682 · KLE
Dental · 200d
Cleared Aug 17, 2020
Cytrans Granules
K192597 · LYC
Dental · 332d
Cleared Jul 09, 2020
GC Temp Print
K193113 · EBG
Dental · 240d
Cleared Jul 02, 2020
GC Fuji Triage EP
K193484 · EMA
Dental · 198d
Cleared Nov 22, 2019
everX Flow
K192260 · EBF
Dental · 93d

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