Clearance Summary
BEGOPAL+ received FDA 510(k) clearance under submission number K123929, sponsored by Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2013-03-14.
- Submission: K123929
- Applicant / Sponsor: Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3710
- Decision date: 2013-03-14
Classification & Regulation
This clearance is catalogued under FDA product code EJH and 21 CFR 872.3710, within the Dental review panel as a Class II device.