FDA · official record K171958Substantially Equivalent

PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE

Name: PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE — FDA K171958
Creator: Mectron S.P.A.
Keywords: PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE, PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE, K171958, DZI, FDA

United StatesDZIMectron S.P.A.

Verified

Official record identity

FDA application number: K171958
Decision date: January 12, 2018
Published decision: Substantially Equivalent

Classification

Product code: DZI

Published parties

Applicant: Mectron S.P.A.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2017-06-29
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4120

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.