Dental artificial intelligence company Overjet has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Dental Assist product.
Overjet Dental Assist is a Software as a Medical Device product, which uses AI in real-time to support dentists and hygienists.
The FDA clearance allows the company to market and sell the AI product directly to dental practices.
The product is designed to help dental professionals to measure mesial and distal bone levels in bitewing and periapical radiographs for the diagnosis and treatment planning of periodontal disease.
According to the company, the disease affects around 46% of US adults, including 8.9% who have severe periodontitis.
Overjet CEO and co-founder Dr Wardah Inam said: “Overjet’s Dental Assist clearance by the FDA is a landmark moment for dental AI.
“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.”
Overjet Dental Assist showed automated measurement capabilities comparable to a team of skilled dentists in clinical performance testing, said the company.
Three dentists from the company had independently measured bone levels on dental radiographs using a measuring tool.
Later, these measurements have been adjudicated by an oral radiologist to create an official consensus ground truth, Overjet said.
The company noted that its AI-powered Dental Assist measurements were later compared against this dentist consensus and had an average difference of only 0.3mm.
To date, three-year-old Overjet has raised $10.5m in venture funding to develop AI models for the detection of a range of dental conditions such as cavities, gum disease, tartar and impacted teeth.
