Cleared Traditional

E-CUBE

K111616 · Saeshin Precision Co., Ltd. · Dental
Aug 2011
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K111616 is an FDA 510(k) clearance for the E-CUBE, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on August 19, 2011, 70 days after receiving the submission on June 10, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K111616 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2011
Decision Date August 19, 2011
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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