Cleared Traditional

PIEZOSURGERY TOUCH

K122322 · Mectron S.P.A. · Dental
Dec 2012
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K122322 is an FDA 510(k) clearance for the PIEZOSURGERY TOUCH, a Drill, Bone, Powered (Class II — Special Controls, product code DZI), submitted by Mectron S.P.A. (Rome, IT). The FDA issued a Cleared decision on December 6, 2012, 127 days after receiving the submission on August 1, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K122322 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2012
Decision Date December 06, 2012
Days to Decision 127 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