Overjet has received 510(k) clearance from the Food and Drug Administration (FDA) for its Dental Assist software as a medical device system, which applies artificial intelligence (AI) in real time to aid dentists and dental hygienists, according to the company. The clearance will enable Overjet to market and sell the system directly to dental practices.
Dental Assist helps dental professionals measure mesial and distal bone levels in bitewing and periapical radiographs for the diagnosis and treatment planning of periodontal disease. The condition affects about 46% of adults in the United States, including 8.9% who have severe periodontitis. Left untreated, periodontitis can lead to tooth loss and painful chewing.
“Overjet’s Dental Assist clearance by the FDA is a landmark moment for dental AI,” said Dr. Wardah Inam, PhD, CEO and cofounder of Overjet.
“All clinicians can now have at their fingertips highly accurate software to detect and measure serious dental disease and clear AI visualizations to communicate with patients. This is big for dentistry and moving toward evidence-based, patient-centric care,” Inam said.
In clinical performance testing, Dental Assist demonstrated automated measurement capabilities comparable to a team of highly skilled dentists, Overjet said.
Three experienced dentists independently measured bone levels on dental radiographs using a measuring tool. These measurements then were further adjudicated by an oral radiologist to establish an official consensus ground truth. Next, Dental Assist measurements were compared to the dentist consensus, with an average difference of only 0.3 mm.
“We’re seeing dental AI software perform at the level of a team of trained dentists with accuracy closer than the width of a needle,” said Dr. Chris Balaban, DMD, clinical director for Overjet.
“These tools unlock the ability to track the progression of disease over time for each tooth and make the case for evidence-based treatment, supported by unbiased software and clear visuals for patients,” Balaban said.