Cleared Traditional

EMS-200

K153285 · Meta Systems Co., Ltd. · Dental

Aug 2016

Decision

274d

Days

Class 1

Risk

About This 510(k) Submission

K153285 is an FDA 510(k) clearance for the EMS-200, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Meta Systems Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on August 12, 2016, 274 days after receiving the submission on November 12, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K153285 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2015
Decision Date	August 12, 2016
Days to Decision	274 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF