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

Denied

GC America, Inc. has 128 FDA 510(k) cleared dental devices. Based in Alsip, US.

Latest FDA clearance: Jul 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.

128 devices

1-12 of 128

1 2 3 4

G aenial Universal Injectable II

1 2 3 4

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Data Source

Sourced from the FDA 510(k) public files . 175,730 total devices indexed.

Last updated: Aug 06, 2026

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

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

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