Cleared Traditional

K181129 - STRONG Dental Handpieces

K181129 is an FDA 510(k) clearance for STRONG Dental Handpieces, manufactured by Saeshin Precision Co., Ltd.. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K181129 · Saeshin Precision Co., Ltd. · Dental device
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Jan 2019
Decision
276d
Days
Class 1
Risk

K181129 is an FDA 510(k) clearance for the STRONG Dental Handpieces. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Saeshin Precision Co., Ltd. (Deagu, KR). The FDA issued a Cleared decision on January 31, 2019 after a review of 276 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 Saeshin Precision Co., Ltd. devices

FDA 510(k) Submission Details - K181129

510(k) Number K181129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2018
Decision Date January 31, 2019
Days to Decision 276 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 127d · This submission: 276d
Pathway characteristics
Predicate-based equivalence.

EGS Device Classification - Class 1, General Controls

Product Code EGS Handpiece, Contra- And Right-angle Attachment, 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 - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 19
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K181129.
General Cutting Contra Handpiece
K202960 · Nakanishi, Inc. · Oct 2020
TRAUS Dental Handpieces
K182892 · Saeshin Precision Co., Ltd. · Nov 2019
General Cutting Contra Handpiece
K182999 · Nakanishi, Inc. · Apr 2019
STRONG Dental Handpieces
K171436 · Saeshin Precision Co., Ltd. · Jan 2018
Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray
K150750 · Sirona Dental Systems GmbH · Jul 2015
TI-MAX Z45
K121901 · Nakanishi, Inc. · Feb 2013