The following data is part of a premarket notification filed by Kaltenbach & Voigt Gmbh with the FDA for Diagnocam.
| Device ID | K123402 |
| 510k Number | K123402 |
| Device Name: | DIAGNOCAM |
| Classification | Caries Detector, Laser Light, Transmission |
| Applicant | KALTENBACH & VOIGT GMBH BISMARCHRING 39 Biberach / Riss, DE 88400 |
| Contact | Stefan Trampler |
| Correspondent | Stefan Trampler KALTENBACH & VOIGT GMBH BISMARCHRING 39 Biberach / Riss, DE 88400 |
| Product Code | NTK |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-05 |
| Decision Date | 2013-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV101055700 | K123402 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DIAGNOCAM 79068175 3692898 Dead/Cancelled |
Kaltenbach & Voigt GmbH 2009-03-02 |