Clearance Summary
BECE CAD ZIRKON HT+ received FDA 510(k) clearance under submission number K132102, 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 2013-11-12.
- Submission: K132102
- Applicant / Sponsor: Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2013-11-12
Classification & Regulation
This clearance is catalogued under FDA product code EIH and 21 CFR 872.6660, within the Dental review panel as a Class II device.