C5 Medical Werks Applies for Clearance, Certification and Licensing for the Global Marketing of ZirDent(TM) Ceramic CAD/CAM Dental Blocks

"Achieving these multiple milestones underscores our dedication to serving unmet needs in the marketplace," said Brad Coors, President and CEO of C5 Medical Werks.

An FDA 510(k) pre-market submission must show that a device is substantially equivalent to a legally marketed device, the "predicate." When equivalency is determined -- usually within 90 days -- the device is then cleared for marketing in the United States. A CE marking (Conformite Europeene) certifies that a product meets the European Union (EU) and European Free Trade Association (EFTA) health, safety and environmental standards for consumer safety. Health Canada requires manufacturers of Class III medical devices to apply for a Medical Device License from the Therapeutics Products Directorate (TPD). ZirDent(TM) is designated a Class III device in Canada.

About C5 Medical Werks

C5 Medical Werks is a leading provider of ceramic solutions for the medical device industry. The Company manufactures medical grade components with an emphasis on ceramic materials. Based in the United States, the company operates a state-of-the art facility from a single, comprehensive quality system certified to ISO 13485:2003 and complies with all other applicable governmental regulations. Product lines include ceramic implantable components to be used in hip, knee, spine and dental applications, as well as other potential custom implant components. C5 Medical Werks excels at manufacturing premium implantable components that help people live better lives.

C5 Medical Werks is located at 2451 River Road, Grand Junction, CO 81505. For more information, please visit http://www.c5medicalwerks.com or call (877) 259-3757.

SOURCE C5 Medical Werks