Cleared Traditional

PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE

K171958 · Mectron S.P.A. · Dental

Jan 2018

Decision

197d

Days

Class 2

Risk

About This 510(k) Submission

K171958 is an FDA 510(k) clearance for the PIEZOSURGERY TOUCH, 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 January 12, 2018, 197 days after receiving the submission on June 29, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number	K171958 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 2017
Decision Date	January 12, 2018
Days to Decision	197 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF