Cleared Traditional

TRAUS SIP20

K201292 · Saeshin Precision Co., Ltd. · Dental
Feb 2021
Decision
273d
Days
Class 1
Risk

About This 510(k) Submission

K201292 is an FDA 510(k) clearance for the TRAUS SIP20, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by Saeshin Precision Co., Ltd. (Deagu, KR). The FDA issued a Cleared decision on February 11, 2021, 273 days after receiving the submission on May 14, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K201292 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2020
Decision Date February 11, 2021
Days to Decision 273 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBW — Controller, Foot, Handpiece And Cord
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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