Impla-NX (Model: ISE-270M)— 510(k) K201192

Substantially Equivalent

Micro-Nx Co., Ltd.

FDA 510(k) clearance K201192 for Impla-NX (Model: ISE-270M), Substantially Equivalent on 2021-05-21. 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: 2020-05-04
Decision date: 2021-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
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.