Overjet's AI Caries Assist Platform Receives FDA Clearance

Caries Assist is designed to allow clinicians to detect caries accurately and reduces the rate of missed lesions.

Dental artificial intelligence company Overjet has received 510(k) clearance for the US Food and Drug Administration (FDA) for its Caries Assist, AI-powered dental caries detection and outlining software for chairside aid and patient communication, the company announced in a press release. The announcement follows the 2021 FDA clearance of Overjet’s Dental Assist platform, which supports dental professionals in measuring mesial and distal bone levels in bitewing and periapical radiographs for the diagnosis and treatment planning of periodontal disease.

Overjet Caries Assist is designed to allow clinicians to detect caries accurately and reduces the rate of missed lesions (false negatives). To demonstrate the validity of the software, Overjet analyzed more than 7000 tooth surfaces. With the aid of Caries Assist, dentists were said to be able to detect 32% more tooth surfaces containing caries, according to the company’s statement.

“Since our inception in 2018, we have been on a quest to improve oral health by creating a future that is clinically precise, efficient, and patient-centric,”  Wardah Inam. PhD, Overjet co-founder and CEO, said in the company’s press release. “Today, with this landmark clearance we are spearheading the transformation with innovative solutions for an industry that collectively wants better patient outcomes. With our Caries Assist, we are here to make a positive impact on the health of millions of Americans.”

With this technology, Overjet will support clinicians to be more effective and efficient by presenting them with accurate findings, identifying anatomical structures and common pathologies, and providing instant visualizations while improving patient-dentist communication.

With Dental Assist and Caries Assist, Overjet is said to be the first dental AI technology company cleared by the FDA able to address both bone level measurement with periodontal disease and dental caries detection, as well as quantification for bone level and outline with caries.