Clearance Summary
MP Pin flat without thread (36BMP000020/MP20) received FDA 510(k) clearance under submission number K240321, 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 2024-10-17.
- Submission: K240321
- Applicant / Sponsor: Hager& Meisinger GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4880
- Decision date: 2024-10-17
Classification & Regulation
This clearance is catalogued under FDA product code DZL and 21 CFR 872.4880, within the Dental review panel as a Class II device.