Clearance Summary
ODONTOSURGE 3 received FDA 510(k) clearance under submission number K001560, sponsored by Odonto-Wave. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-08-24.
- Submission: K001560
- Applicant / Sponsor: Odonto-Wave
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4920
- Decision date: 2000-08-24
Classification & Regulation
This clearance is catalogued under FDA product code EKZ and 21 CFR 872.4920, within the Dental review panel as a Class II device.