Cleared Traditional

TRAUS Air Dental Handpiece

K221741 · Saeshin Precision Co., Ltd. · Dental
Feb 2023
Decision
252d
Days
Class 1
Risk

About This 510(k) Submission

K221741 is an FDA 510(k) clearance for the TRAUS Air Dental Handpiece, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on February 22, 2023, 252 days after receiving the submission on June 15, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K221741 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2022
Decision Date February 22, 2023
Days to Decision 252 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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