Lead case · updated 2026-10-31
AI in aligner treatment planning: what an FDA clearance does and does not tell you
FDA cleared an optional AI-enabled prediction service inside a clear-aligner treatment-planning system on Sep 25, 2026. We read the clearance summary and set out what it does and does not show.
Short answer
Too early to say. The clearance summary reports that pre-set acceptance criteria were met but publishes no figures.
- Remote monitoring L2 · Regulatory record
- AI ceph landmarking L3 · Peer-reviewed study