Cleared Traditional

STRONG DENTAL HANDPIECES

K100192 · Saeshin Precision Co., Ltd. · Dental
Feb 2010
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K100192 is an FDA 510(k) clearance for the STRONG DENTAL HANDPIECES, a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on February 4, 2010, 13 days after receiving the submission on January 22, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K100192 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2010
Decision Date February 04, 2010
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EGS — Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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