Medical Device Manufacturer · US , Alsip , IL

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

129 submissions · 129 cleared · Since 1993

Recent clearances: Cerasmart Forte, Cytrans™ Elashield, SRGC-06

View 129 510(k) Devices ↓

129

Total

129

Cleared

Denied

GC America, Inc. has 129 FDA 510(k) cleared dental devices. Based in Alsip, US.

Latest FDA clearance: Sep 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 26021 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.

129 devices

1-12 of 129

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 . 176,583 total devices indexed.

Last updated: Oct 05, 2026

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

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

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