Crystal Ultra is manufacturered in Germany in a facility that special-purpose certified as a ISO 13485 Medical Manufacturing facility specifically for the purpose of "Design, manufacture and sale of dental materials based on resins, glasses, ceramics and cements, auxiliar agents and accessories.
DLMS conducts periodic on-site and remote audits and inspections of the manufacturing facilities and processes to insure the highest standards of quality.
Additionally, the facilities and processes are their compliance with ISO 13485 stanards are certified annually by DQS Medizinproduckte GmbH, a German UL-registered firm specializing in certification of German quality management systems. The facility was certified according to the newest 2012 version of the ISO 13485 standard in November of 2013.
Additional information about the manufacturing processes are confidential, but if you would like more information, please use our contact us form.