Cleared Traditional

CamX Triton HD Proxi Head

K172007 · Duerr Dental AG · Dental
Nov 2017
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K172007 is an FDA 510(k) clearance for the CamX Triton HD Proxi Head, a Caries Detector, Laser Light, Transmission (Class II — Special Controls, product code NTK), submitted by Duerr Dental AG (Bietigheim-Bissingen, DE). The FDA issued a Cleared decision on November 22, 2017, 142 days after receiving the submission on July 3, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number K172007 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2017
Decision Date November 22, 2017
Days to Decision 142 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