Clearance Summary
BISICO IMPRESSION SILICONES & ALGINATES received FDA 510(k) clearance under submission number K072577, sponsored by Bisico 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 2007-12-05.
- Submission: K072577
- Applicant / Sponsor: Bisico GmbH & CO KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 2007-12-05
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.