Clearance Summary
EVERSTICK received FDA 510(k) clearance under submission number K011788, sponsored by Stick Tech , 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 2001-11-05.
- Submission: K011788
- Applicant / Sponsor: Stick Tech , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 2001-11-05
Classification & Regulation
This clearance is catalogued under FDA product code EBI and 21 CFR 872.3760, within the Dental review panel as a Class II device.