Medical Device Manufacturer · US , New York , NY

Coltene/Whaledent AG - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2005

Recent clearances: BRILLIANT COMPONEER, BRILLIANT EverGlow Flow, BRILLIANT Crios

Total

Cleared

Denied

Coltene/Whaledent AG has 16 FDA 510(k) cleared dental devices. Based in New York, US.

Historical record: 16 cleared submissions from 2005 to 2019.

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 Emergo Global Consulting, LLC as regulatory consultant.

Coltene/Whaledent AG 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 - Coltene/Whaledent AG

16 devices

1-16 of 16

BRILLIANT EverGlow Flow

PARAPOST PARACORE AUTOMIX 5ML

Data Source

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

Last updated: Jun 01, 2026

Coltene/Whaledent AG - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Coltene/Whaledent AG

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