Argen Equals Quality
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.
Here is technical data on some alloys we presently use at Impressive Dental Studio. If you or your patient has a need for a different type of alloy, please contact us at 1-800-944-1244, and we'll try to accommodate your needs.