510(k) DEN990002

KAVO DIAGNODENT by Kavo America — Product Code NBL

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