Clearance Summary
SaliPen received FDA 510(k) clearance under submission number K180838, sponsored by Saliwell , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2018-11-06.
- Submission: K180838
- Applicant / Sponsor: Saliwell , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5560
- Decision date: 2018-11-06
Classification & Regulation
This clearance is catalogued under FDA product code LTF and 21 CFR 872.5560, within the Dental review panel as a Class II device.