Clearance Summary
Kava and Kava with Herbst received FDA 510(k) clearance under submission number K182661, sponsored by Sketchpad Innovations, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2019-02-13.
- Submission: K182661
- Applicant / Sponsor: Sketchpad Innovations, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2019-02-13
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.