FDA Clearance of BlueCheck Caries Detection

Posted: June 16, 2023
Edited by Hygienetown staff

MELBOURNE, Aus.—Incisive Technologies announces the US Food and Drug Administration (FDA) has issued 510K clearance for BlueCheck Caries Detection and Monitoring, a novel caries detection device used by clinicians in dental examinations to aid the detection of early caries.

BlueCheck specifically binds to active caries lesions and provides a visible blue color, aiding dental professionals by providing a direct and objective measure of disease. It is a specifically designed biomolecule, consisting of a protein, linker and dye, that selectively and reversibly binds to sites of dental demineralization. BlueCheck is painted on, then a simple rinse washes away unbound BlueCheck, to reveal the active caries via the remaining bound blue color.

BlueCheck will initially be launched in the U.S. with other markets to follow and will be available from September through US dental sales and distribution channels.

For more information, visit incisive-technologies.com.

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