The following data is part of a premarket notification filed by Kavo America with the FDA for Diagnodent.
| Device ID | K051909 |
| 510k Number | K051909 |
| Device Name: | DIAGNODENT |
| Classification | Laser, Fluorescence Caries Detection |
| Applicant | KAVO AMERICA PO BOX 7007 Deer Field, IL 60015 |
| Contact | Deniel Kamm |
| Correspondent | Deniel Kamm KAVO AMERICA PO BOX 7007 Deer Field, IL 60015 |
| Product Code | NBL |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-14 |
| Decision Date | 2005-10-21 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DIAGNODENT 75489165 2299572 Live/Registered |
KAVO DENTAL GMBH 1998-05-21 |