Cleared Traditional

X-CUBE

K092758 · Saeshin Precision Co., Ltd. · Dental
Sep 2009
Decision
12d
Days
Class 1
Risk

About This 510(k) Submission

K092758 is an FDA 510(k) clearance for the X-CUBE, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on September 21, 2009, 12 days after receiving the submission on September 9, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K092758 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2009
Decision Date September 21, 2009
Days to Decision 12 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBW — Controller, Foot, Handpiece And Cord
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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