Clearance Summary
CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO received FDA 510(k) clearance under submission number K051443, sponsored by Curasan Ag, Frankfurt Facility. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2005-07-22.
- Submission: K051443
- Applicant / Sponsor: Curasan Ag, Frankfurt Facility
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2005-07-22
Classification & Regulation
This clearance is catalogued under FDA product code LYC and 21 CFR 872.3930, within the Dental review panel as a Class II device.