Overjet, a dental artificial intelligence (AI) company, has received FDA 501(k) clearance for its Periapical Radiolucency (PARL) Assist device. This innovative product is designed to assist dentists in detecting and segmenting instances of PARL on periapical radiographs. With this clearance, Overjet has become the first and only dental AI provider capable of detecting and outlining instances of PARL on periapical radiographs in patients aged 12 and above, setting a new record in the dental AI field.
The development of PARL Assist involved extensive clinical expertise, rigorous testing, and validation. Overjet’s algorithms were trained using tens of thousands of clinically validated instances of periapical radiolucencies, with annotations provided by expert clinicians. The AI model’s efficiency and quality of testing contributed to the swift FDA clearance, with Dr. Deepthi Paknikar leading the record-breaking process.
Dr. Teresa Dolan, chief dental officer at Overjet, expressed the significance of AI in dentistry, stating that dentists can now leverage AI to identify teeth that require endodontic testing and observation or potentially treatment. This precise segmentation of the lesion can greatly improve patient communication and understanding. Periapical lesions can be challenging to detect as they are often symptomless and can have various causes, such as tooth decay, trauma, or previous dental procedures.
Overjet’s PARL Assist product will aid clinicians in identifying and alerting them to potential instances of PARL alongside pre-existing clearances. The AI technology was developed in collaboration with practicing dentists and Overjet’s clinical team, incorporating feedback from several customers who participated in a BETA program. Dentists who participated in the program praised the accuracy of Overjet’s detection and segmentation, noting that instances of PARL are particularly difficult to detect and diagnose compared to caries.
PARL Assist is already being used by leading dental service organizations (DSOs) and dental practices, and Overjet plans to release the functionality for all customers in the coming weeks as a standard component in its Clinical Intelligence Platform. This latest achievement solidifies Overjet’s position as a pioneer and leader in dental AI, furthering its mission to provide dentists with advanced tools for improved patient care.
Dr. Wardah Inam, founder and CEO of Overjet, emphasized the company’s commitment to delivering the best outcomes for patients. She stated that working closely with customers and in-house clinicians, they identified PARL as a key area that is both challenging to detect and critically important to oral health. With the release of PARL Assist, Overjet aims to continue revolutionizing dental care by providing dentists with advanced AI-powered solutions.