Clearance Summary
EBS (ESPE BONDING SYSTEM) received FDA 510(k) clearance under submission number K962428, sponsored by Espe GmbH & Co. Kg.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1996-09-12.
- Submission: K962428
- Applicant / Sponsor: Espe GmbH & Co. Kg.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3200
- Decision date: 1996-09-12
Classification & Regulation
This clearance is catalogued under FDA product code KLE and 21 CFR 872.3200, within the Dental review panel as a Class II device.