C5 Medical Werks applies for clearance, certification, licensing for global marketing of ZirDent

May 12, 2008
Independent assessments verify safety and quality of technically advanced zirconium oxide material for ceramic CAD/CAM dental blocks.

DENVER, Colorado--C5 Medical Werks, a provider of ceramic solutions for the medical device industry, has submitted a 510(k) pre-market notification to the U.S. Food and Drug Administration for its new technical ceramic dental component, ZirDent CAD/CAM Blocks.

ZirDent is a zirconium material suited to meet the high esthetic and physical property needs of the dental market. Additionally, the company has been assessed recently for the CE certification 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 day--the device is then cleared for marketing in the United States.

A CE marking (Conformite Europeene) certifies that a product meets the European Union and European Free Trade Association 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. ZirDent is designated a Class III device in Canada.

For more information about C5 Medical Werks, visit C5 Medical Werks or call (877) 259-3757.

To read more about CAD/CAM, go to CAD/CAM.

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