AI that reads your X-rays: what it flags, and what it doesn't decide
FDA-cleared software can now mark suspected decay and other findings on dental X-rays. It highlights; your dentist still diagnoses.
If your dentist turns the screen toward you and the X-ray has colored boxes on it, you are probably looking at dental AI. The software scans the image and marks areas it thinks deserve a closer look. It is a second set of eyes. It is not the diagnosis.
What is actually cleared
This is no longer a lab experiment. A narrative review in the International Dental Journal, published in December 2025, searched FDA databases through July 2025 and counted 29 FDA-cleared AI products for dental imaging from 13 companies. They cover tasks such as detecting decay, measuring bone levels around teeth, charting, and analyzing 3D scans.
Two names come up often. The review lists Overjet with nine cleared modules, including decay and calculus detection, and Pearl with seven, including multi-condition detection on bitewing and periapical X-rays, the small films taken inside the mouth.
Coverage is widening. On December 18, 2025, Pearl announced FDA 510(k) clearance for its Second Opinion software to flag suspected cavities, periapical radiolucencies (dark areas near root tips that can signal infection) and impacted wisdom teeth on panoramic X-rays, the wide image that wraps around the whole jaw. That is a company announcement. Pearl says the clearance was supported by a standalone performance study and a multi-reader study, and the trade press coverage reported no accuracy figures.
What it means for you
- A flagged spot is a prompt, not a verdict. Your dentist decides whether it is real and whether it needs treatment, watching, or nothing.
- The overlay can make X-rays easier to understand. Seeing a marked area is often clearer than squinting at shades of gray.
- It does not replace an exam. X-rays are one input alongside what your dentist sees, feels and knows about your history.
- No flag does not mean no problem. Software can miss things, just as people can.
What the evidence does not yet show
FDA clearance means a product met the agency's requirements for its stated use. It is not a promise that it performs the same in every office. The same review notes a scarcity of independent, external validation studies, and says several newer platforms lacked independent clinical validation. Much of the published performance data comes from the companies themselves.
That is not a reason to fear the boxes on the screen. It is a reason to treat them as one more opinion in the room.
What to ask at your visit
If your dentist uses AI on your X-rays, ask what it flagged, whether they agree, and what they would recommend if the software were switched off. A good answer explains the finding in plain language and connects it to what they saw in your mouth. If treatment is suggested, it should make sense without the software doing the convincing.
Sources
Educational content, not individual medical advice. Every mouth is different, so talk to a licensed dentist about your own teeth. The Real Miami Dentists is powered by 5 Star Smiles.
