Cleared Special

TRAUS ENDO

K212043 · Saeshin Precision Co., Ltd. · Dental
Jun 2022
Decision
359d
Days
Class 1
Risk

About This 510(k) Submission

K212043 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 24, 2022, 359 days after receiving the submission on June 30, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K212043 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2021
Decision Date June 24, 2022
Days to Decision 359 days
Submission Type Special
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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