It’s a question that comes up frequently: what is the difference between FDA cleared and FDA approved?
The answer is simple: FDA cleared is the designation for Class II medical devices – such as Overjet – that meet the Food and Drug Administration’s standards.
FDA approved is the designation for Class III medical devices that meet its standards.
Medical Device Categories
The FDA classifies medical devices into three categories:
- Class I is the lowest risk, and 95% of medical devices in this category are exempt from the regulatory process.
- Class II devices undergo an FDA review to determine safety, quality, and effectiveness, then will be designated as FDA cleared if approved.
- Class III devices typically sustain or support life, such as pacemakers, and require a more extensive review before they are eligible to receive FDA approval.
Companies need to submit their clinical findings to the FDA for review, and these become part of the public record.
Overjet’s FDA-Cleared Dental AI
Overjet’s AI software for dental radiographs has two FDA clearances. One is for the quantification of bone level measurements. Overjet is the only company in the world that has been FDA-cleared for this technology. Bone loss is one of the indicators of periodontal (gum) disease. The Centers for Disease Control and Prevention estimates 47.2% of adults over the age of 30 have some form of periodontal disease.
The other FDA clearance is for the detection and outlining of caries (cavities) on bitewing radiographs. Dentists can use the findings to determine the appropriate treatment and help their patients achieve better outcomes. The earlier problems are spotted, the easier and less expensive they are to treat.
Is FDA Clearance Needed to Identify Prior Restorations?
Not all AI functions require FDA clearance, particularly if they are low risk or don’t drive treatment or diagnostic decisions. For example, Overjet’s dental AI software detects fillings, crowns, bridges, implants, root canals and other restorations. This does not require FDA clearance.
Innovating to Enhance Patient Care
Overjet continues to innovate with the goal of enhancing patient care. In May 2022, Forbes named Overjet one of North America’s Top A.I. Companies Shaping the Future on its annual Forbes AI 50 list. Overjet’s AI models combine computer vision, natural language processing, deep learning, advanced data science methods, and advanced statistical models to process millions of data points and return accurate, precise, and consistent results.
To see how Overjet can help your practice, schedule a demo today.
