Clearance Summary
PASR/QUIETNITE received FDA 510(k) clearance under submission number K093340, sponsored by Exact Supplies , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2010-06-11.
- Submission: K093340
- Applicant / Sponsor: Exact Supplies , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2010-06-11
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.