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Argen operates under the auspices of the U.S. Food and Drug Administration and complies with their Good Manufacturing Practices. We are ISO 13485 certified, and comply with the European Medical Device Directive (93/42/EEC.) Tests are performed in accordance with ISO harmonized standards. Where applicable, individual alloys are further certified to meet NIOM, ADA or DIN standards. What does all this mean to you? Third party certification of our Quality System via ISO 13485 means that our entire operation including research, purchasing raw materials, manufacturing, technical and customer services, has been independently audited to meet international standards. The CE mark further confirms that the materials have been determined to be safe and effective for their intended purpose.
The research & development department has the most technically advanced analytical equipment in the world. This helps keep us abreast of all cutting edge technology. We market our products worldwide & have a range of more then 600 alloys. We have comparable alloys to most of the alloys manufactured worldwide and we have an alloy that is compatible with all major porcelain systems. We have brought to market more new alloys than any other manufacturer. By keeping up with world trends we are able to swiftly react to market fluctuations. The technical department has become the benchmark against which others are measured. Our highly experienced technicians are able to solve virtually any problem on the phone. In addition, we analyze problem cases in our laboratory & send detailed reports on our findings. Although we are an alloy manufacturer, we will solve all technical problems even if they relate to porcelain or other non metal causes.
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