Clearance Summary
MS Lide Implant Systems received FDA 510(k) clearance under submission number K181477, sponsored by Hangzhou Minsheng Lide Medical Science & Technology 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 2020-10-20.
- Submission: K181477
- Applicant / Sponsor: Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2020-10-20
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.