Cleared Traditional

STRONG Dental Handpieces

K171436 · Saeshin Precision Co., Ltd. · Dental
Jan 2018
Decision
234d
Days
Class 1
Risk

About This 510(k) Submission

K171436 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. (Deagu, KR). The FDA issued a Cleared decision on January 5, 2018, 234 days after receiving the submission on May 16, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K171436 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2017
Decision Date January 05, 2018
Days to Decision 234 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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