FDA OKs Incisive Technologies’ caries detection device

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Incisive Technologies for its new caries detection device.

BlueCheck caries detection and monitoring helps dentists detect early tooth decay by using the natural hydroxyapatite-binding chemistry of proteins. The biomolecule, which consists of a protein, linker, and dye, binds to sites of dental demineralization. BlueCheck is painted on, then a rinse washes away the unbound material to reveal active caries via a remaining blue color. Due to the electrostatic interaction, toothbrushing and interaction with saliva remove the blue color.

Initially, BlueCheck will be launched in the U.S., with other markets to follow. In September, it will be available through U.S. dental sales and distribution channels.