Clearance Summary
CERASORB PLUS received FDA 510(k) clearance under submission number K120152, sponsored by Riemser Arzneimittel AG. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-08-13.
- Submission: K120152
- Applicant / Sponsor: Riemser Arzneimittel AG
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2012-08-13
Classification & Regulation
This clearance is catalogued under FDA product code NPM and 21 CFR 872.3930, within the Dental review panel as a Class II device.