Meg-Torq

FDA 510(k) K161500 · Micro-Nx Co., Ltd.

Substantially Equivalent

510(k) numberK161500

Submission

Device name
Meg-Torq
Applicant
Micro-Nx Co., Ltd.
Daegu, KR
Received
June 1, 2016
Decision date
February 22, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EKX – Handpiece, Direct Drive, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

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Questions and answers

When was Meg-Torq cleared by the FDA?

Meg-Torq (K161500) received a 510(k) decision of Substantially Equivalent on February 22, 2017, 266 days after the submission was received.

What is the product code of K161500?

The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.