Dental News - Dental AI start-up Overjet receives second FDA clearance for software

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Dental AI start-up Overjet receives second FDA clearance for software

Overjet has received 510(k) clearance from the FDA for its Caries Assist software. (Image: Syda Productions/Shutterstock)

BOSTON, US: Overjet, a dental start-up that develops software powered by artificial intelligence (AI), recently announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its product Caries Assist. The software uses AI to help dentists better identify tooth decay and outline the carious lesion and is the second Overjet product to receive this type of clearance.

Overjet demonstrated the validity of Caries Assist by having dental professionals use the software to analyse more than 7,000 tooth surfaces. According to the company, dentists who were aided by Caries Assist were able to detect 32% more surfaces with caries than those who were unaided.

“This milestone is a demonstration of our strong commitment to complying with the highest quality standards and regulatory requirements,” said Dr Adam Odeh, director of regulatory affairs and quality assurance at Overjet. He added: “I’m very proud of our regulatory team, and growing team of engineers and clinicians. Together, we’ve been able to expand the versatility of our platform with a strong foundation in research.”

Founded in 2018 by Dr Wardah Inam, Overjet was previously granted 510(k) clearance in 2021 for Dental Assist, software that can measure bone levels in radiographs of patients with periodontal disease.

In recognition of its promise, Overjet was recently placed on Forbes’ AI 50 2022 list, which highlights the most promising AI-centric companies based in North America. According to the magazine, Overjet is valued at US$425 million (€131 million) and has partnerships with large dental insurers, including Guardian and Delta Dental as well as Dental Care Alliance, one of the largest dental support organisations in the US.

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