Incisive Technologies Receives FDA Clearance for BlueCheck Caries Detection and Monitoring

Australia: Incisive Technologies, a Melboune-based company dedicated to advancing enamel decay research, has announced that its first product, BlueCheck™ Caries Detection and Monitoring, has received 510K clearance from the US Food and Drug Administration (FDA). This product is designed to aid dental professionals in the detection of early caries during routine dental examinations.

Visible Indication of Caries

BlueCheck utilizes a specially designed biomolecule that selectively and reversibly binds to sites of dental demineralization, specifically active caries lesions. When applied to the tooth surface, BlueCheck provides a visible blue coloration, offering a direct and objective measure of disease presence. The device’s unique chemistry targets porous surface and sub-surface lesions, thanks to its affinity for hydroxyapatite, a key component of tooth enamel.

Dr Jonathan Mangum, Chief Scientific Officer and inventor of the technology, explains, “By using the natural hydroxyapatite-binding chemistry of proteins, the BlueCheck molecule effectively targets caries lesions. It consists of a protein, linker, and dye, and when applied to the tooth, it selectively binds to demineralized areas, revealing the active caries through the remaining bound blue color.”

Aiding Early Caries Detection

The FDA clearance of BlueCheck signifies its potential to support dental professionals in various aspects of patient care, says the company. The device aims to provide objective evidence of caries lesion status, aiding in diagnosis, treatment planning, and ongoing monitoring. 

Kerry Hegarty, CEO of Incisive Technologies, emphasizes the importance of early caries detection, stating, “Early detection of dental caries and the differentiation of their activity status are keys to success and de-risk the challenges with caries diagnosis. BlueCheck gives the clinician objective evidence in detecting and monitoring early caries. Our aim is to help simplify the management of caries”

BlueCheck addresses the need for earlier detection of dental caries, enabling dental professionals to supplement their evaluation accurately and efficiently. The device’s ability to differentiate between active caries and arrested lesions offers clinicians crucial information for providing appropriate preventive measures and personalized care.

“We’ve worked directly with dentists, orthodontists, and research collaborators to understand how our technology can support the shift towards earlier caries detection and improved prevention. BlueCheck gives clinicians objective evidence in detecting and monitoring early caries, simplifying caries management and supporting minimally invasive care,” said Hegarty.

Click here for more information on BlueCheck Caries Detection and Monitoring by Incisive Technologies.