Cleared Traditional

Impla-NX (Model: ISE-270M)

K201192 · Micro-Nx Co., Ltd. · Dental
May 2021
Decision
382d
Days
Class 1
Risk

About This 510(k) Submission

K201192 is an FDA 510(k) clearance for the Impla-NX (Model: ISE-270M), 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 May 21, 2021, 382 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 K201192 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2020
Decision Date May 21, 2021
Days to Decision 382 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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