Overjet Receives Second FDA Clearance, Adding Overjet Caries Assist to the Industry's #1 Dental AI Platform
The first and only chairside dental AI technology cleared by the FDA that can both quantify bone levels with periodontal disease, and detect and outline tooth decay for accurate patient care and communication.
BOSTON -- Overjet, the leader in dental AI solutions for payers and providers, today announced that it received FDA 510(k) clearance for its Caries Assist, AI-powered dental caries detection and outlining software for chairside aid and patient communication.
This new milestone follows Overjet's FDA clearance in 2021 of its Dental AssistTM, the first FDA clearance of its kind for bone level measurement in X-rays with periodontal disease. With Dental AssistTM and Caries Assist, Overjet is the first and only dental AI company with technology 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.
According to the CDC, periodontal disease and dental caries (bone loss and cavities) are two of the biggest threats to dental health. Tooth decay remains the most prevalent chronic disease in both children and adults, even though it is largely preventable, greatly reducing the quality of life of 2.3 billion people worldwide. Oral health and overall health are inextricably linked. According to a new Delta Dental study, gum disease has a close link to heart disease, diabetes, lung illness, and dementia, among other serious health issues.
"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," said Dr. Wardah Inam, Co-Founder and CEO of Overjet. "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 commercially available 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 to support better patient outcomes.
"Our motivation for utilizing an Al solution at Mortenson Dental Partners is to aid in the early diagnosis of dental decay, and periodontal disease and that's where Overjet excels in assisting our clinicians," said Dr. Eric Tobler, National Clinical Director of Mortenson Dental Partners, one of the largest dental groups in the US. "We've been impressed with Overjet's ability to help our patients understand and visualize what's going on in their mouth."
Overjet Caries Assist enables clinicians to detect caries accurately and reduces the rate of missed lesions (false negatives). To demonstrate the validity of the software, the Company analyzed more than 7,000 tooth surfaces. With the aid of Overjet Caries Assist, dentists were able to detect 32% more tooth surfaces containing caries.
"This milestone is a demonstration of our strong commitment to complying with the highest quality standards and regulatory requirements," said Dr. Adam Odeh who leads the regulatory team and the efforts at Overjet. "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. It's clear that everyone at Overjet is deeply dedicated to bringing this technology to the tens of thousands of clinicians and millions of patients in the US, and I'm excited to be part of this journey."
"We're very excited about this important milestone," said Dr. Terri Dolan, Chief Dental Officer of Overjet. "This FDA clearance further validates the breadth of our AI platform. Overjet goes beyond specific AI algorithms to act as a chairside, software as a medical device enhancing clinical decision-making in dental practices around the country. By bringing both bone level measurement with periodontal disease and dental caries detection, as well as quantification for bone level and outline with caries, we enable comprehensive care to be delivered to the right patient with the right treatment at the right time."
Overjet's FDA-cleared Dental AssistTM, and Claim Intelligence Platforms are already in use by some of the largest dental groups and insurance companies, covering over 75 million Americans.