Cleared Special

PIEZON 150

K132443 · E.M.S Electro Medical Systems S.A · Dental
Nov 2013
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K132443 is an FDA 510(k) clearance for the PIEZON 150, 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 November 22, 2013, 108 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 K132443 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2013
Decision Date November 22, 2013
Days to Decision 108 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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