Cleared Special

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

Class I Dental device.

K231562 · Micro-Nx Co., Ltd. · Dental device
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Optimized for regulatory review, auditing and printing
Jul 2025
Decision
779d
Days
Class 1
Risk

K231562 is an FDA 510(k) clearance for the ELEC ENGINE (Model: ISE-170L). 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 July 18, 2025 after a review of 779 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Micro-Nx Co., Ltd. devices

Submission Details

510(k) Number K231562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2023
Decision Date July 18, 2025
Days to Decision 779 days
Submission Type Special
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
652d slower than avg
Panel avg: 127d · This submission: 779d
Pathway characteristics
Modification to existing cleared device.

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
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