Cleared Special

ELEC ENGINE (Model: ISE-170L)

K231562 · Micro-Nx Co., Ltd. · Dental
Jul 2025
Decision
779d
Days
Class 1
Risk

About This 510(k) Submission

K231562 is an FDA 510(k) clearance for the ELEC ENGINE (Model: ISE-170L), 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 July 18, 2025, 779 days after receiving the submission on May 31, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K231562 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2023
Decision Date July 18, 2025
Days to Decision 779 days
Submission Type Special
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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