Cleared Traditional

K141886 - MDK HANDPIECES

K141886 is an FDA 510(k) clearance for MDK HANDPIECES, manufactured by Modern Korea Co., Ltd.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K141886 · Modern Korea Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
303d
Days
Class 1
Risk

K141886 is an FDA 510(k) clearance for the MDK HANDPIECES. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Modern Korea Co., Ltd. (Fullerton, US). The FDA issued a Cleared decision on May 13, 2015 after a review of 303 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.

FDA 510(k) Submission Details - K141886

510(k) Number K141886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2014
Decision Date May 13, 2015
Days to Decision 303 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
175d slower than avg
Panel avg: 128d · This submission: 303d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

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 247
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K141886.
AIR-FLOW handy 3.0 PLUS
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K141576 · Kavo DO Brasil Industria E Comercio Ltda · May 2015
Codent Low Speed Dental Handpieces and Accessories
K150798 · Codent Technical Industry Co., Ltd. · Apr 2015
EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES
K141183 · Ttbio Corp. · Feb 2015
K141886 · MDK HANDPIECES
Download PDF FDA Summary Modern Korea Co., Ltd.