FDA-cleared AI dental devices
The FDA's AI-enabled device list has 7 devices whose lead review panel is Dental, 0.4% of all 1,614 listed devices. They come from 7 companies. The first decision was on January 11, 2018 and the most recent on May 8, 2026.
7AI devices
7Companies
2018First decision
2026-05-08Latest decision
Trend: devices per year
201820242026
Top companies
Most common product codes
All 7 devices, newest first
- LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd. · Dental
- TRIOS Dx (R1)3Shape TRIOS A/S · Dental
- DentalMonitoringDental Monitoring SAS · Dental
- RAYDENT SWRAY Co., Ltd. · Dental
- X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · Dental
- MATRx plusZephyr Sleep Technologies · Dental
- CEREC Ortho SoftwareDentsply Sirona · Dental
Frequently asked questions
How many FDA-cleared AI dental devices are there?
As of the FDA list updated through June 29, 2026, 7 AI-enabled devices have Dental as their lead review panel (0.4% of the list).
Which companies have the most AI dental devices?
Hangzhou ChohoTech Co., Ltd. (1), 3Shape TRIOS A/S (1), Dental Monitoring SAS (1) have the most AI-enabled dental devices on the FDA list.
Which year had the most AI dental authorizations?
2024 had the most, with 3 devices.
Which FDA pathways are used for AI dental devices?
510(k): 5; De Novo: 2.
What was the most recent AI dental device on the list?
LingOral Dental Design System from Hangzhou ChohoTech Co., Ltd. (K260419), with a decision dated May 8, 2026.