operates under the auspices of the U.S. Food and Drug Administration
and complies with their Good Manufacturing Practices. Jelenko's quality
system is ISO 13485 certified. Tests are performed in accordance with
ISO harmonized standards. Where applicable, individual alloys are
further certified to meet NIOM, ADA or DIN standards.
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.