May 28 2008
C5 Medical Werks, a leading provider of ceramic solutions for the medical device industry, has submitted a 510(k) pre-market notifi cation to the U.S. Food and Drug Administration (FDA) for its new technical ceramic dental component, ZirDent™ CAD/CAM Blocks. ZirDent™ is a zirconium oxide material ideally suited to meet the high aesthetic and physical property needs of the dental market. Additionally, the Company has been assessed recently for the CE certifi cation of ZirDent™ by the British Standards Institute and has also applied to Health Canada for a medical device license for the product.
“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 (Conformité Européene) certifi es 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™ is designated a Class III device in Canada.