Cleared Traditional

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

Class I Dental device.

K201192 · Micro-Nx Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
382d
Days
Class 1
Risk

K201192 is an FDA 510(k) clearance for the Impla-NX (Model: ISE-270M). Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Micro-Nx Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on May 21, 2021 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Micro-Nx Co., Ltd. devices

Submission Details

510(k) Number K201192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
255d slower than avg
Panel avg: 127d · This submission: 382d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBW Controller, Foot, Handpiece And Cord
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

LK Consulting Group USA, Inc.
Priscilla Chung

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBW Controller, Foot, Handpiece And Cord

All 60
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K201192.
Motor Handpiece and Control Unit (SDI10)
K251407 · Saeshin Precision Co., Ltd. · Jan 2026
Star E900 Electric System
K251701 · Dentalez, Inc., Stardental Division · Jan 2026
Motor and Apex Module (MaAM)
K251811 · Dentsply Sirona, Inc. · Aug 2025
ELEC ENGINE (Model: ISE-170L)
K231562 · Micro-Nx Co., Ltd. · Jul 2025
Dental Implant Unit
K242646 · Guilin Aesthedent Medical Instruments Co., Ltd. · Apr 2025
NLZ Built-In Motor System
K233288 · Nakanishi, Inc. · Jun 2024