Cleared Traditional

Dental Low-speed Handpieces and Accessories (K202786) - FDA 510(k) Clearance

Class I Dental device.

K202786 · Microp Technology (Taiwan), Inc. · Dental device
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Sep 2021
Decision
346d
Days
Class 1
Risk

K202786 is an FDA 510(k) clearance for the Dental Low-speed Handpieces and Accessories. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Microp Technology (Taiwan), Inc. (Chiayi City, TW). The FDA issued a Cleared decision on September 3, 2021 after a review of 346 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 Microp Technology (Taiwan), Inc. devices

Submission Details

510(k) Number K202786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2020
Decision Date September 03, 2021
Days to Decision 346 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
219d slower than avg
Panel avg: 127d · This submission: 346d
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
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