Cleared Traditional

TRAUS ENDO

K143411 · Saeshin Precision Co., Ltd. · Dental
Jun 2015
Decision
213d
Days
Class 1
Risk

About This 510(k) Submission

K143411 is an FDA 510(k) clearance for the TRAUS ENDO, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on June 29, 2015, 213 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 K143411 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2014
Decision Date June 29, 2015
Days to Decision 213 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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