Cleared Traditional

DIAGNOCAM

K123402 · Kaltenbach & Voigt GmbH · Dental
Sep 2013
Decision
323d
Days
Class 2
Risk

About This 510(k) Submission

K123402 is an FDA 510(k) clearance for the DIAGNOCAM, a Caries Detector, Laser Light, Transmission (Class II — Special Controls, product code NTK), submitted by Kaltenbach & Voigt GmbH (Biberach / Riss, DE). The FDA issued a Cleared decision on September 24, 2013, 323 days after receiving the submission on November 5, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number K123402 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2012
Decision Date September 24, 2013
Days to Decision 323 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NTK — Caries Detector, Laser Light, Transmission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1745