Medical Device Manufacturer · US , Alsip , IL

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

126 submissions · 126 cleared · Since 1993

Recent clearances: G-CEM UNIVERSAL, G-Bond Universal, EQUIA LC ONE

126

Total

126

Cleared

0

Denied

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

126 devices

1-12 of 126

1 2 3 4

Cleared May 18, 2026

G-CEM UNIVERSAL

Cleared Oct 02, 2025

G-Bond Universal

Cleared Sep 19, 2025

Cleared Aug 29, 2025

G aenial Universal Injectable II

Cleared Nov 24, 2020

Cleared Oct 02, 2020

Cleared Aug 17, 2020

Cytrans Granules

Cleared Jul 09, 2020

Cleared Jul 02, 2020

GC Fuji Triage EP

Cleared Nov 22, 2019

Cleared Jul 11, 2019

GC FujiCEM 2 (Improved)

Cleared Nov 20, 2018

GC Acrylic Primer

1 2 3 4

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Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Jun 05, 2026