Clearance Summary
EVERSTICK ORTHO received FDA 510(k) clearance under submission number K021126, 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 2002-05-13.
- Submission: K021126
- Applicant / Sponsor: Stick Tech , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 2002-05-13
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.