DENVER, May 12 C5 Medical Werks, a leading provider ofceramic solutions for the medical device industry, has submitted a 510(k)pre-market notification to the U.S. Food and Drug Administration (FDA) for itsnew technical ceramic dental component, ZirDent(TM) CAD/CAM Blocks.ZirDent(TM) is a zirconium material ideally suited to meet the high aestheticand physical property needs of the dental market. Additionally, the Companyhas been assessed recently for the CE certification of ZirDent(TM) by theBritish Standards Institute and has also applied to Health Canada for amedical device license for the product.
"Achieving these multiple milestones underscores our dedication to servingunmet needs in the marketplace," said Brad Coors, President and CEO ofC5 Medical Werks.
An FDA 510(k) pre-market submission must show that a device issubstantially equivalent to a legally marketed device, the "predicate." Whenequivalency is determined -- usually within 90 days -- the device is thencleared for marketing in the United States. A CE marking (ConformiteEuropeene) certifies that a product meets the European Union (EU) and EuropeanFree Trade Association (EFTA) health, safety and environmental standards forconsumer safety. Health Canada requires manufacturers of Class III medicaldevices to apply for a Medical Device License from the Therapeutics ProductsDirectorate (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 themedical device industry. The Company manufactures medical grade componentswith an emphasis on ceramic materials. Based in the United States, the companyoperates a state-of-the art facility from a single, comprehensive qualitysystem certified to ISO 13485:2003 and complies with all other applicablegovernmental regulations. Product lines include ceramic implantable componentsto be used in hip, knee, spine and dental applications, as well as otherpotential custom implant components. C5 Medical Werks excels at manufacturingpremium 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