510(k) DEN990002
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 22, 2000
- Date Received
- July 12, 1999
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Fluorescence Caries Detection
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type