Cleared Traditional

TRAUS SUS10

K151171 · Saeshin Precision Co., Ltd. · Dental
Sep 2015
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K151171 is an FDA 510(k) clearance for the TRAUS SUS10, a Drill, Bone, Powered (Class II — Special Controls, product code DZI), submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on September 1, 2015, 123 days after receiving the submission on May 1, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K151171 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2015
Decision Date September 01, 2015
Days to Decision 123 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