Clearance Summary
SICAT OPTISLEEP received FDA 510(k) clearance under submission number K153291, sponsored by Sicat GmbH & Co. KG. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2016-03-31.
- Submission: K153291
- Applicant / Sponsor: Sicat GmbH & Co. KG
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2016-03-31
Classification & Regulation
This clearance is catalogued under FDA product code LRK and 21 CFR 872.5570, within the Dental review panel as a Class II device.