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.
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