Cleared Traditional

EMS PIEZON 707 BIK AND PIEZON 707 BIK LED

K140990 · E.M.S Electro Medical Systems S.A · Dental
Feb 2015
Decision
316d
Days
Class 2
Risk

About This 510(k) Submission

K140990 is an FDA 510(k) clearance for the EMS PIEZON 707 BIK AND PIEZON 707 BIK LED, 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 February 27, 2015, 316 days after receiving the submission on April 17, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K140990 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2014
Decision Date February 27, 2015
Days to Decision 316 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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