Cleared Traditional

STRONG Dental Handpieces

K143418 · Saeshin Precision Co., Ltd. · Dental
Jul 2015
Decision
245d
Days
Class 1
Risk

About This 510(k) Submission

K143418 is an FDA 510(k) clearance for the STRONG Dental Handpieces, a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on July 31, 2015, 245 days after receiving the submission on November 28, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K143418 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2014
Decision Date July 31, 2015
Days to Decision 245 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EGS — Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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