Navigation Links
C5 Medical Werks Applies for Clearance, Certification and Licensing for the Global Marketing of ZirDent(TM) Ceramic CAD/CAM Dental Blocks

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 or call (877) 259-3757.

SOURCE C5 Medical Werks
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. MSU engineering team designs innovative medical device
2. ATS Medical to Present at the 2007 Thomas Weisel Partners Healthcare Conference
3. Providence St. Joseph Medical Center, Caregivers Reach Agreement on a Union Contract
4. Owner and Operator of Florida Durable Medical Equipment Company Convicted of Medicare Fraud
5. Father and Daughter From Tanzania Receive Their First Medical Examination in Newport Beach
6. Doctors and medical ethicist discuss whether doctors should participate in capital punishment
7. Preparation for Natural Disasters Critical for People With Diabetes, Chronic Medical Conditions
8. Doctors and Medical Ethicist Discuss Whether Doctors Should Participate in Capital Punishment
9. Symmetry Medical Completes Acquisition Of Specialty Surgical Instruments
10. Milestone Scientific Announces Successful Completion of its Collaboration Agreement With Carticept Medical
11. FDA Seeks to Regulate Complementary and Alternative Medicine; Products Such as Vegetable Juice Could Be Restricted for Medical Use
Post Your Comments:
(Date:11/30/2015)... ... November 30, 2015 , ... Until now, the St. Louis ... the MOMS (Management of Myelomeningocele Study) trial. One of these exclusion criteria was a ... BMI of 18.5 to 24.9 is considered normal, 25 - 29.9 is overweight and ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... . The directory is specialized and only includes chiropractic clinics in the US. ... competent and trustworthy alternative health practitioner when back pain sets in. When people ...
(Date:11/30/2015)... Creek, Michigan (PRWEB) , ... November 30, 2015 , ... ... MI, the American Cancer Society held an annual fundraising event, a 5K walk known ... a holistic treatment center for substance abuse which is also located in Battle Creek, ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... a University of Delaware Accounting and Management of Information Systems course. Based in ... mid-market businesses. Sommer will speak at before student in the Enterprise Resource Planning ...
(Date:11/30/2015)... Baltimore, MD (PRWEB) , ... November 30, 2015 , ... ... has teamed up with Public Television’s Travel With Kids to promote ... follows the Simmons family as they explore international destinations and educate families about the ...
Breaking Medicine News(10 mins):
(Date:11/30/2015)... , Nov. 30, 2015  The ... norm in U.S. medical imaging is on ... popular accountable care payer-provider contracts are set ... in their wake, alter provider-vendor relationships. The ... will push forward new purchasing frameworks in ...
(Date:11/30/2015)... , Nov. 30, 2015 Cumberland Pharmaceuticals (CPIX), ... present live at on December 3, 2015. ... TIME: 3:15p.m. ET LINK: ... LINK: --> ... event where investors are invited to ask the company questions ...
(Date:11/30/2015)... Nov. 30, 2015 Varian Medical Systems (NYSE: VAR ... educational partnership with Apollo Hospitals Group, the largest hospital chain in ... help train radiation technologists in the country. The MoU was signed ... Knowledge, and Ashok Kakkar , Varian,s India ... India , Varian intends to deploy its Access ...
Breaking Medicine Technology: