Clearance Summary
Portable Dental X-ray Device (GT-1) received FDA 510(k) clearance under submission number K254018, sponsored by Guilin Refine Medical Instrument Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2026-02-19.
- Submission: K254018
- Applicant / Sponsor: Guilin Refine Medical Instrument Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2026-02-19
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.