DECLARATION OF CONFORMITY

 

THE ARGEN CORPORATION

located at
5855 Oberlin Drive San Diego,CA92121-4718
declares, under our sole responsibility,
The Following Dental Alloy Product:

ArgenZ HT+

Complies with the legislation of

ISO 13485 - Medical Devices - Particular requirements for the application of ISO 9001;

Following the Provisions of

93/42/EEC; Annex II - Council of European Communities Directive Concerning
Medical Devices.


 

Manufacturer

EC Representative

THE ARGEN CORPORATION

Medical Device Safety Service Gmbh,

5855 Oberlin Drive

Schiffgraben 41, D-30175

San Diego, CA 92121-4718

Hannover,Germany


Issued By:

Craig Jolicoeur
Quality and Regulatory Assurance Manager

** This document is generated electronically and does not require a signature **

Print date: 5/21/2024