Cleared Traditional

ELEC-LED

K201191 · Micro-Nx Co., Ltd. · Dental
Feb 2022
Decision
644d
Days
Class 1
Risk

About This 510(k) Submission

K201191 is an FDA 510(k) clearance for the ELEC-LED, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by Micro-Nx Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on February 7, 2022, 644 days after receiving the submission on May 4, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K201191 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2020
Decision Date February 07, 2022
Days to Decision 644 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBW — Controller, Foot, Handpiece And Cord
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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