Overjet, the pioneer and leader in dental AI, announced FDA 501(k) clearance for its Periapical Radiolucency (PARL) Assist device. PARL Assist is a first-of-its-kind product that aids dentists in detecting and segmenting instances of PARL on periapical radiographs. This achievement marks Overjet’s 5th FDA Clearance, setting a record in the dental AI space.
With this latest clearance, Overjet becomes the first and only dental AI provider capable of detecting and outlining instances of PARL on periapical radiographs in patients aged 12 and above. This milestone follows a pattern of innovation from Overjet, which became the first FDA-cleared provider of AI-powered Bone Level measurements in 2021 and the first and only FDA-cleared provider of AI-powered Caries Segmentation in 2022.
In developing PARL Assist, Overjet drew on significant clinical expertise, conducting thorough testing and validation. Tens of thousands of clinically validated instances of periapical radiolucencies across a wide range of clinical scenarios were annotated by expert clinicians to train Overjet’s algorithms. The reference standard testing set, which establishes the quality bar for its AI, was built by Overjet with explicit multi-consensus agreement from expert US licensed endodontists.
“Dentists, for the first time in their clinical lifetimes, will be able to leverage AI in order to identify teeth that require endodontic testing and observation or potentially treatment, and utilize the precise segmentation (outlines) of the lesion to drastically improve patient communication and understanding. Periapical lesions can be caused by tooth decay, trauma to the tooth, or a previous dental procedure, and are often ‘silent’ with patients presenting without symptoms, while potentially active infection is persisting,” said Dr. Teresa Dolan, chief dental officer at Overjet. “Beyond the clear benefits of accuracy and consistency, Overjet’s technology plays a critical role in helping doctors educate patients about their oral health.”
Overjet’s PARL Assist product will identify and alert clinicians in a number of clinical scenarios in conjunction with pre-existing clearances. Two example scenarios include:
- Teeth that have carious lesions that extend into the pulp in conjunction with a PARL lesion will be explicitly called out to the clinician in the platform.
- Teeth with pre-existing root canal therapy that have potentially unresolved PARL’s will be explicitly flagged and an alert sent to the clinician to further investigate and test clinically.
The quality of the AI model and testing led to the most efficient clearance in the dental AI space to date. Dr. Deepthi Paknikar led this record-breaking process at Overjet. Her experience as both an AI regulatory expert and a US licensed dentist gives her and the team a competitive edge in the market. “We’re honored to see the successful and speedy FDA clearance for PARL Assist. More innovation is on its way from Overjet, and I’m excited to support our development efforts and put new capabilities through appropriate regulatory scrutiny.”
“From day one, our focus has been on delivering the best outcomes for patients. That’s why we continue to invest in building AI that gives dentists the best possible insights and packages these learnings in a format that patients can understand,” said Dr. Wardah Inam, founder and CEO of Overjet. “Working closely with our customers and in-house clinicians, we identified PARL as a key area that is both challenging to detect and critically important to oral health. Today we’re proud to share the world’s first PARL Segmentation AI and announce its FDA clearance.”
Like its prior major FDA-cleared solutions, Overjet developed PARL Assist in close partnership with practicing dentists and its in-house clinical team of over 10 clinicians. Several Overjet customers provided feedback and participated in a BETA program in advance of today’s announcement.
Dentists that participated in the BETA noted that “the technology is especially impactful given that instances of PARL are harder to detect and diagnose compared to caries.” Referring to the accuracy of Overjet’s detection and segmentation, a BETA dentist shared that “It was really spot on, even caught instances of PARL which I did not even pay attention to.”
Overjet’s new PARL Assist product is already in active use with several leading DSOs and dental practices.
In the coming weeks, Overjet plans to release the functionality for all of its customers as a standard component in its Clinical Intelligence Platform.