Ultimate Wireforms, Inc.'s Quality Management System is certified to the highest levels of ISO 13485 (Quality Management System for Medical Devices) and incorporates full compliance requirements with CE Marking and the FDA QSR. Our orthodontic products conform to the provisions of the European Medical Device Directive (93/42/EEC), Annex II, for full quality assurance system. This compliance, as assessed by TUV Rheinland of North America, allows us to apply the "CE Mark" to our orthodontic products. In addition, Ultimate Wireforms, Inc. is an FDA registered manufacturer and adheres to Quality Systems Regulations (Good Manufacturing Practices) as prescribed in the Code of Federal Regulations. © 2008 Ultimate Wireforms, Inc.           All Rights Reserved           1.800.999.NITI(6484)