DENVER, June 2 /PRNewswire/ -- C5 Medical Werks, a manufacturer of high-quality ceramic solutions for the medical device industry, has received clearance from the U.S. Food and Drug Administration (FDA) to market the Company’s ZirDent(TM) CAD/CAM Blocks. The pre-formed ceramic dental blanks combine high-fracture toughness with advanced aesthetic characteristics and are intended for CAD/CAM fabrication by the customer of zirconia (zirconium oxide) crowns and/or bridges for dental restorations.
ZirDent(TM) CAD/CAM Blocks are available in an unlimited variety of shapes, sizes and sintering options -- pre-sintered, fully sintered and HIP’d -- to meet each customer’s unique specifications. In their 510(k) clearance letter, the FDA found ZirDent(TM) Dental Blocks to be substantially equivalent to competitive zirconia ceramic blocks currently sold to the U.S. dental profession.
Additionally, the Company has received CE certification for ZirDent(TM) from the British Standards Institute, allowing the marketing of the product in Europe. The Conformite Europeene (CE) marking process ensures the medical device meets the European Union (EU) and European Free Trade Association (EFTA) health, safety and environmental standards for consumer safety.
“Achieving compliance and meeting the exacting standards required for the medical marketing of ZirDent(TM) in the United States and Europe is a major milestone for us,” said Andrew Nield, Director of Sales and Marketing for C5 Medical Werks.
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 an FDA registered, state-of-the-art facility with a single, comprehensive quality system certified to ISO 13485:2003, compliant with FDA’s Quality System Regulation (21 CFR 820) and meeting all other applicable governmental requirements. Product lines include ceramic implantable components to be used in hip, knee, spine and dental applications, as well as other custom implant components. C5 Medical Werks excels at manufacturing premium implantable components that help people live better lives.
C5Medical 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.
CONTACT: Andrew Nield, Director of Sales and Marketing for C5 Medical
Werks, +1-303-618-6798, anield@c5medicalwerks.com; or Marge D. Hansen,
1-800-445-7602, mhansen@griffsmc.com, for C5 Medical Werks
Web site: http://www.c5medicalwerks.com/
