Clearance Summary
CEPHX3D received FDA 510(k) clearance under submission number K252538, sponsored by Orca Dental AI , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-03-05.
- Submission: K252538
- Applicant / Sponsor: Orca Dental AI , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2026-03-05
Classification & Regulation
This clearance is catalogued under FDA product code QIH and 21 CFR 892.2050, within the Radiology review panel as a Class II device.