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Evidence and regulation for dental AI
Some dental software uses artificial intelligence (AI). Before trusting a tool, check if a regulator has cleared it and what it was cleared to do.
This is general information, not a diagnosis. It does not replace a check by a dentist or doctor. If you are worried, contact a dental professional.
What the FDA list is
- The U.S. FDA keeps a list of AI-enabled medical devices that are authorised for sale in the U.S.
- Devices on the list have met the FDA's premarket rules, including a review of safety and effectiveness for their stated use.
- The list is not complete. It is found mainly by searching for AI terms in FDA documents.
How this site checks tools
- Our AI tools directory links each regulatory claim to the regulator's own record where we found one.
- When we could not confirm a status, we say “not verified”.
- We note the date we last checked.
Questions to ask
- What exactly is the tool cleared to do?
- Who checks its results? A dentist should always make the final decision.
- Where is my data stored?
Related: Digital imaging
Sources
Paraphrased in plain words. Links checked and accessed 21 Oct 2026.
- U.S. Food and Drug Administration. “Artificial intelligence-enabled medical devices”. https://www.fda.gov/medical-devices/artificial-intelligence-enabled-medical-devices/list-artificial-intelligence-enabled-medical-devices (accessed 21 Oct 2026).
- U.S. Food and Drug Administration. “Dental cone-beam computed tomography”. https://www.fda.gov/radiation-emitting-products/medical-x-ray-imaging/dental-cone-beam-computed-tomography (accessed 21 Oct 2026).