Cleared Traditional

EMS PIEZON MASTER 700

K093000 · E.M.S Electro Medical Systems S.A · Dental
Jul 2010
Decision
305d
Days
Class 2
Risk

About This 510(k) Submission

K093000 is an FDA 510(k) clearance for the EMS PIEZON MASTER 700, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by E.M.S Electro Medical Systems S.A (North Attleboro, US). The FDA issued a Cleared decision on July 30, 2010, 305 days after receiving the submission on September 28, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K093000 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2009
Decision Date July 30, 2010
Days to Decision 305 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELC — Scaler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4850

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