Cleared Traditional

TRAUS SUS20

K192561 · Saeshin Precision Co., Ltd. · Dental
Jul 2020
Decision
300d
Days
Class 2
Risk

About This 510(k) Submission

K192561 is an FDA 510(k) clearance for the TRAUS SUS20, a Drill, Bone, Powered (Class II — Special Controls, product code DZI), submitted by Saeshin Precision Co., Ltd. (Deagu, KR). The FDA issued a Cleared decision on July 13, 2020, 300 days after receiving the submission on September 17, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K192561 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2019
Decision Date July 13, 2020
Days to Decision 300 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZI — Drill, Bone, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120

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