Cleared Traditional

PIEZOSURGERY WHITE

K151248 · Mectron S.P.A. · Dental
Sep 2015
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K151248 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 September 4, 2015, 116 days after receiving the submission on May 11, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K151248 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2015
Decision Date September 04, 2015
Days to Decision 116 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