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

Denied

GC America, Inc. has 126 FDA 510(k) cleared dental devices. Based in Alsip, US.

Latest FDA clearance: May 2026. Active since 1993.

Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Wood Burditt Group as regulatory consultant.

GC America, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

126 devices

1-12 of 126

1 2 3 4

G aenial Universal Injectable II

GC FujiCEM 2 (Improved)

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

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

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

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