Clearance Summary
Bio-MEM Ti Reinforced Membrane received FDA 510(k) clearance under submission number K210797, sponsored by B&Medi 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 2022-08-18.
- Submission: K210797
- Applicant / Sponsor: B&Medi Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2022-08-18
Classification & Regulation
This clearance is catalogued under FDA product code NPK and 21 CFR 872.3930, within the Dental review panel as a Class II device.