Cleared Special

PIEZON 250

K132445 · E.M.S Electro Medical Systems S.A · Dental
Dec 2013
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K132445 is an FDA 510(k) clearance for the PIEZON 250, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by E.M.S Electro Medical Systems S.A (Marlborough, US). The FDA issued a Cleared decision on December 6, 2013, 122 days after receiving the submission on August 6, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K132445 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2013
Decision Date December 06, 2013
Days to Decision 122 days
Submission Type Special
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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