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C5 Medical Werks Seeking Certification and Licensing for Dental Blocks (posted 5/21/08)

May 21, 2008
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C5 Medical Werks has submitted a 510(k) pre-market notification to the U.S. Food and Drug Administration (FDA) for its new technical ceramic dental component, ZirDent™ CAD/CAM Blocks. ZirDent is a zirconium material that is reportedly ideally suited to meet the high aesthetic and physical property needs of the dental market. Additionally, the company was recently assessed for the CE certification of ZirDent by the British Standards Institute and has 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 chief executive officer 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 U.S. 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 is designated a Class III device in Canada.

For more information, call (877) 259-3757 or visit www.c5medicalwerks.com.

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