Cleared Traditional

K161500 - MEG-TORQ

K161500 is an FDA 510(k) clearance for MEG-TORQ, manufactured by Micro-Nx Co., Ltd.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K161500 · Micro-Nx Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
266d
Days
Class 1
Risk

K161500 is an FDA 510(k) clearance for the MEG-TORQ. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Micro-Nx Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on February 22, 2017 after a review of 266 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Micro-Nx Co., Ltd. devices

FDA 510(k) Submission Details - K161500

510(k) Number K161500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 127d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

EKX Device Classification - Class 1, General Controls

Product Code EKX Handpiece, Direct Drive, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKX Handpiece, Direct Drive, Ac-powered

All 46
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K161500.
Young INFINITY Cordless Handpiece System
K171377 · Young Dental Manufacturing Co. 1, LLC · Aug 2018
IS3
K180527 · Hiossen, Inc. · May 2018
Tri Auto ZX2
K170275 · J. Morita USA, Inc. · Sep 2017
MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology
K160825 · Dentsply Sirona · Sep 2016
IPROPHY MOBILE
K131578 · Nakanishi, Inc. · Sep 2013
TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE
K112665 · J. Morita USA, Inc. · May 2012