510(k) DEN990002
DEN990002 is an FDA 510(k) premarket notification submitted by Kavo America for the device "KAVO DIAGNODENT". The FDA issued a decision of De Novo granted on Feb 22, 2000. The device falls under product code NBL (Light-Induced Fluorescence Caries Detector), a Class II device regulated under 21 CFR 872.1745. Kavo America has 19 other 510(k) clearances on record.
Clearance details
- Decision
- DENG (De Novo granted)
- Decision Date
- Feb 22, 2000
- Date Received
- Jul 12, 1999
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Light-Induced Fluorescence Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type
- 510(k)