Clearance Summary
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) received FDA 510(k) clearance under submission number K251438, sponsored by Guilin Woodpecker Medical Instrument Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-09-04.
- Submission: K251438
- Applicant / Sponsor: Guilin Woodpecker Medical Instrument Co., Ltd.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2025-09-04
Classification & Regulation
This clearance is catalogued under FDA product code EHD and 21 CFR 872.1800, within the Dental review panel as a Class II device.