Clearance Summary
BIORES Dental Implant System received FDA 510(k) clearance under submission number K252286, sponsored by Chengdu Besmile Medical Technology Co., Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2026-02-02.
- Submission: K252286
- Applicant / Sponsor: Chengdu Besmile Medical Technology Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2026-02-02
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.