ELEC ENGINE (Model: ISE-170L)— 510(k) K231562

Name: FDA 510(k) clearance K231562
Creator: U.S. Food and Drug Administration
Published: 2025-07-18

Substantially Equivalent

Micro-Nx Co., Ltd.

FDA 510(k) clearance K231562 for ELEC ENGINE (Model: ISE-170L), Substantially Equivalent on 2025-07-18. Applicant: Micro-Nx Co., Ltd.. Device class: 1.

Clearance details

Applicant: Micro-Nx Co., Ltd.
Product code: Code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2023-05-31
Decision date: 2025-07-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.