Tracker · Updated October 2026
FDA-cleared dental AI tracker (2026)
12 dental AI tools in the Dental AI Tools directory hold 41 FDA clearances or De Novo grants between them, the most recent dated August 6, 2026. Every number below links straight to the FDA database, and we checked each one there on October 28, 2026.
Pearl (Second Opinion)
Pearl, Inc. · Our score 8.9/10| FDA number | Device name (as listed by FDA) | Decision date |
|---|---|---|
| K250525 | Second Opinion Panoramic | November 14, 2025 |
| K243234 | Second Opinion CS | June 12, 2025 |
| K243989 | Second Opinion 3D | May 23, 2025 |
| K243230 | Second Opinion BLE | May 9, 2025 |
| K243893 | Second Opinion Pediatric | May 5, 2025 |
| K242600 | Second Opinion Periapical Radiolucency Contours | April 11, 2025 |
| K242522 | Second Opinion CC | January 16, 2025 |
| K210365 | Second Opinion | March 4, 2022 |
Overjet
Overjet, Inc. · Our score 8.8/10| FDA number | Device name (as listed by FDA) | Decision date |
|---|---|---|
| K261059 | Overjet Multi-Image Caries and Charting Assist | August 6, 2026 |
| K253930 | Overjet Iris Intelligent Imaging System | April 10, 2026 |
| K251514 | Overjet CBCT Assist | December 5, 2025 |
| K241681 | Overjet Image Enhancement Assist | September 9, 2024 |
| K241684 | Overjet Charting Assist | August 27, 2024 |
| K233738 | Overjet Caries Assist-Pediatric | March 4, 2024 |
| K233590 | Overjet Charting Assist | February 23, 2024 |
| K231678 | Overjet Periapical Radiolucency Assist | September 21, 2023 |
| K222746 | Overjet Caries Assist | March 27, 2023 |
| K220928 | Overjet Calculus Assist | December 16, 2022 |
| K212519 | Overjet Caries Assist | May 10, 2022 |
| K210187 | Overjet Dental Assist | May 19, 2021 |
Videa
VideaHealth, Inc. · Our score 8.8/10VELMENI
Velmeni, Inc. · Our score 7.5/10Denti.AI
Denti.Ai Technology, Inc. · Our score 7.2/10Diagnocat
DGNCT, LLC · Our score 7.8/10CephX
Orca Dental AI, Ltd. · Our score 7.6/10DEXIS (DTX Studio Clinic)
Nobel Biocare AB · Our score 8.5/10DentalMonitoring
Dental Monitoring SAS · Our score 8.2/10| FDA number | Device name (as listed by FDA) | Decision date |
|---|---|---|
| DEN230035(De Novo) | DentalMonitoring (De Novo) | May 17, 2024 |
SoftSmile VISION
SoftSmile, Inc. · Our score 7.7/10| FDA number | Device name (as listed by FDA) | Decision date |
|---|---|---|
| K212770 | Vision | December 21, 2021 |
ArchForm
ArchForm, Inc. · Our score 7.6/10| FDA number | Device name (as listed by FDA) | Decision date |
|---|---|---|
| K213916 | ArchForm Orthodontic Software System | December 16, 2021 |
uLab Systems
uLab Systems, Inc. · Our score 7.8/10How we built this list
We only list tools that are in our independently reviewed directory, and only clearances we verified ourselves in the FDA's 510(k) and De Novo databases (accessdata.fda.gov). A clearance covers the specific device and indications FDA reviewed, not every feature a vendor sells. In imaging, FDA clearance is one part of the evidence factor in our methodology. Spot a missing or outdated clearance? Tell us.