Clearance Summary
X O ODONTOSURGE 4 received FDA 510(k) clearance under submission number K023672, sponsored by Xo Care A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2003-04-29.
- Submission: K023672
- Applicant / Sponsor: Xo Care A/S
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4920
- Decision date: 2003-04-29
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.