Cleared Traditional

MEG-TORQ

K161500 · Micro-Nx Co., Ltd. · Dental
Feb 2017
Decision
266d
Days
Class 1
Risk

About This 510(k) Submission

K161500 is an FDA 510(k) clearance for the MEG-TORQ, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Micro-Nx Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on February 22, 2017, 266 days after receiving the submission on June 1, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K161500 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2016
Decision Date February 22, 2017
Days to Decision 266 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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