Cleared Traditional

K192809 - Dental Handpiece

K192809 is an FDA 510(k) clearance for Dental Handpiece, manufactured by Micro-Nx Co., Ltd.. The device is a Class 1 Dental device with product code EFA cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K192809 · Micro-Nx Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
329d
Days
Class 1
Risk

K192809 is an FDA 510(k) clearance for the Dental Handpiece. Classified as Handpiece, Belt And/or Gear Driven, Dental (product code EFA), Class I - General Controls.

Submitted by Micro-Nx Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on August 25, 2020 after a review of 329 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

FDA 510(k) Submission Details - K192809

510(k) Number K192809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2019
Decision Date August 25, 2020
Days to Decision 329 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
202d slower than avg
Panel avg: 127d · This submission: 329d
Pathway characteristics
Predicate-based equivalence.

EFA Device Classification - Class 1, General Controls

Product Code EFA Handpiece, Belt And/or Gear Driven, Dental
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

K-Bio Solutions
Kyungyoon Kang

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.

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