Cleared Traditional

MULTIPIEZO PRO, MULTIPIEZO

K140965 · Mectron S.P.A. · Dental
Aug 2014
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K140965 is an FDA 510(k) clearance for the MULTIPIEZO PRO, MULTIPIEZO, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Mectron S.P.A. (Rome, IT). The FDA issued a Cleared decision on August 20, 2014, 127 days after receiving the submission on April 15, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K140965 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2014
Decision Date August 20, 2014
Days to Decision 127 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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