Clearance Summary
MEISINGER BENEX, MODEL BE001 received FDA 510(k) clearance under submission number K062130, 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 2007-04-16.
- Submission: K062130
- Applicant / Sponsor: Hager& Meisinger GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 2007-04-16
Classification & Regulation
This clearance is catalogued under FDA product code EMG and 21 CFR 872.4565, within the Dental review panel as a Class I device.