Dental AI that detects findings on radiographs, intraoral scanners and many CAD/CAM devices are regulated medical devices. A 510(k) clearance covers specific indications — for example caries detection on bitewings — not everything the product does.
Each clearance has a K-number you can look up in the FDA database; we link them where we have them.
From our data: We have 32 products with an FDA 510(k) or De Novo record on file.
Which dental products need clearance
Software that analyses radiographs to detect or measure disease, intraoral scanners, CBCT units, milling systems and resins intended for use in the mouth are medical devices. Scheduling, billing and general practice management software are not.
Clearance is specific. An AI tool cleared to detect caries on bitewings in adults is not thereby cleared for periapical lesions or for children. Read the indications for use on the clearance summary.
How to verify a claim
Search the FDA 510(k) database by company or K-number. The summary states the device, its intended use and the predicate device. “FDA registered” is not the same thing: registration only means the company is listed with the agency.
Examples
- 3M True Definition — Intraoral scanners
- Denti.AI — AI radiograph analysis
- DTX Studio Clinic — Imaging software
- exoplan — Implant planning
- iTero Lumina — Intraoral scanners
- Lucitone Digital Print — Digital dentures
- Medit i700 — Intraoral scanners
- Navident — Dynamic navigation
Go deeper
FAQ
Is FDA cleared the same as FDA approved?
No. Approval refers to the stricter premarket approval route for high-risk devices. Most dental devices and dental AI reach the market through 510(k) clearance or the De Novo pathway.