The following data is part of a De Novo classification by Kavo America with the FDA for Kavo Diagnodent.
DeNovo ID | DEN990002 |
Device Name: | KAVO DIAGNODENT |
Classification | Laser, Fluorescence Caries Detection |
Applicant | KAVO AMERICA 340 East Main St. Lake Zurich, IL 60047 |
Contact | Douglas Cochrane |
Product Code | NBL |
CFR Regulation Number | 872.1745 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | K983658 |
Review Advisory Board | Dental |
Classification Advisory | Dental |
Type | Post-NSE |
Date Received | 1999-07-12 |
Decision Date | 2000-02-22 |
Reclassification Order: | Reclassification Order |