Cleared Traditional

Piezosurgery White

K171326 · Mectron S.P.A. · Dental
Apr 2018
Decision
343d
Days
Class 2
Risk

About This 510(k) Submission

K171326 is an FDA 510(k) clearance for the Piezosurgery White, a Drill, Bone, Powered (Class II — Special Controls, product code DZI), submitted by Mectron S.P.A. (Carasco, IT). The FDA issued a Cleared decision on April 13, 2018, 343 days after receiving the submission on May 5, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K171326 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2017
Decision Date April 13, 2018
Days to Decision 343 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZI — Drill, Bone, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120