Clearance Summary
KAVO DIAGNODENT received FDA 510(k) clearance under submission number DEN990002, sponsored by Kavo America. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-02-22.
- Submission: DEN990002
- Applicant / Sponsor: Kavo America
- Clearance pathway: Post-NSE
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1745
- Decision date: 2000-02-22
Classification & Regulation
This clearance is catalogued under FDA product code NBL and 21 CFR 872.1745, within the Dental review panel as a Class II device.