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 |