FDA · official record K163640Substantially Equivalent

QZA and RS Dental Implant Systems

Name: QZA and RS Dental Implant Systems — FDA K163640
Creator: Trinon Titanium GmbH
Keywords: QZA and RS Dental Implant Systems, QZA and RS Dental Implant Systems, K163640, DZE, FDA

United StatesDZETrinon Titanium GmbH

Verified

Official record identity

FDA application number: K163640
Decision date: May 03, 2017
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Trinon Titanium GmbH

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2016-12-23
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3640

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.