Cleared Traditional

TRAUS SIP10

K123695 · Saeshin Precision Co., Ltd. · Dental

Dec 2012

Decision

15d

Days

Class 1

Risk

About This 510(k) Submission

K123695 is an FDA 510(k) clearance for the TRAUS SIP10, a Handpiece, Water-powered (Class I — General Controls, product code EKY), submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on December 18, 2012, 15 days after receiving the submission on December 3, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K123695 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 03, 2012
Decision Date	December 18, 2012
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF