Cleared Traditional

DEXIS CariVu 3-in-1 by KaVo

K182712 · Kaltenbach & Voigt GmbH · Dental
Nov 2019
Decision
422d
Days
Class 2
Risk

About This 510(k) Submission

K182712 is an FDA 510(k) clearance for the DEXIS CariVu 3-in-1 by KaVo, a Caries Detector, Laser Light, Transmission (Class II — Special Controls, product code NTK), submitted by Kaltenbach & Voigt GmbH (Biberach, DE). The FDA issued a Cleared decision on November 23, 2019, 422 days after receiving the submission on September 27, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number K182712 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2018
Decision Date November 23, 2019
Days to Decision 422 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