Dental Handpiece— 510(k) K192809

Substantially Equivalent

Micro-Nx Co., Ltd.

FDA 510(k) clearance K192809 for Dental Handpiece, Substantially Equivalent on 2020-08-25. Applicant: Micro-Nx Co., Ltd.. Device class: 1.

Clearance details

Applicant: Micro-Nx Co., Ltd.
Product code: Code EFA
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2019-10-01
Decision date: 2020-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Micro-Nx Co., Ltd.

K231562 — ELEC ENGINE (Model: ISE-170L)2025-07-18
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K220577 — Dental Handpiece, Model CA160, CA160L, and CA500L2022-07-29
K201191 — ELEC-LED2022-02-07
K201192 — Impla-NX (Model: ISE-270M)2021-05-21

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