Independent assessments worldwide verify safety and quality of technically
advanced zirconium oxide material.
DENVER, May 12 /PRNewswire/ -- C5 Medical Werks, a leading 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 (FDA) for
its new technical ceramic dental component, ZirDent(TM) CAD/CAM Blocks.
ZirDent(TM) is a zirconium 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 certification of
ZirDent(TM) 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 (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(TM) is designated a Class
III device in Canada.
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 a state-of-the art facility from a single, comprehensive
quality system certified to ISO 13485:2003 and complies with all other
applicable governmental regulations. Product lines include ceramic
implantable components to be used in hip, knee, spine and dental
applications, as well as other potential custom implant components. C5
Medical Werks excels at manufacturing premium 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
 back to top
Related links:
http://www.c5medicalwerks.com
CONTACT:
Andrew Nield, Director of Sales and Marketing
of C5 Medical Werks, +1-303-618-6798, anield@c5medicalwerks.com;
or Marge D. Hansen, 1-800-443-7602, mhansen@griffsmc.com, for C5
Medical Werks
|
