Cleared Traditional

STRONG Dental Handpieces

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

About This 510(k) Submission

K181129 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 31, 2019, 276 days after receiving the submission on April 30, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K181129 FDA.gov
FDA Decision Cleared 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

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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