Clearance Summary
BEGOPAL 300 received FDA 510(k) clearance under submission number K983081, sponsored by Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1998-10-28.
- Submission: K983081
- Applicant / Sponsor: Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3060
- Decision date: 1998-10-28
Classification & Regulation
This clearance is catalogued under FDA product code EJS and 21 CFR 872.3060, within the Dental review panel as a Class II device.