DIAGNOCAM

Caries Detector, Laser Light, Transmission

KALTENBACH & VOIGT GMBH

The following data is part of a premarket notification filed by Kaltenbach & Voigt Gmbh with the FDA for Diagnocam.

Pre-market Notification Details

Device IDK123402
510k NumberK123402
Device Name:DIAGNOCAM
ClassificationCaries Detector, Laser Light, Transmission
Applicant KALTENBACH & VOIGT GMBH BISMARCHRING 39 Biberach / Riss,  DE 88400
ContactStefan Trampler
CorrespondentStefan Trampler
KALTENBACH & VOIGT GMBH BISMARCHRING 39 Biberach / Riss,  DE 88400
Product CodeNTK  
CFR Regulation Number872.1745 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-05
Decision Date2013-09-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EKAV101055700 K123402 000

Trademark Results [DIAGNOCAM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIAGNOCAM
DIAGNOCAM
79068175 3692898 Dead/Cancelled
Kaltenbach & Voigt GmbH
2009-03-02

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