Cleared Traditional

Dental High-speed Handpiece and Accessories (K173943) - FDA 510(k) Clearance

Class I Dental device.

K173943 · Microp Technology (Taiwan), Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
210d
Days
Class 1
Risk

K173943 is an FDA 510(k) clearance for the Dental High-speed Handpiece and Accessories. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Microp Technology (Taiwan), Inc. (Chiayi County, TW). The FDA issued a Cleared decision on July 24, 2018 after a review of 210 days - an extended review cycle.

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. Standard predicate reliance. 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 Microp Technology (Taiwan), Inc. devices

Submission Details

510(k) Number K173943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2017
Decision Date July 24, 2018
Days to Decision 210 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
83d slower than avg
Panel avg: 127d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, 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 Peers - EFB Handpiece, Air-powered, Dental

All 36
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K173943.
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