Clearance Summary
MyPlant II Implant System received FDA 510(k) clearance under submission number K173819, sponsored by Hager& Meisinger GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2018-08-09.
- Submission: K173819
- Applicant / Sponsor: Hager& Meisinger GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2018-08-09
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.