Navigation Links
C5 Medical Werks Applies for Clearance, Certification and Licensing for the Global Marketing of ZirDent(TM) Ceramic CAD/CAM Dental Blocks
Date:5/12/2008

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
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:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... (PRWEB) , ... December 08, 2016 , ... ... technologies and development solutions for drugs, biologics and consumer health products, today announced ... was set up in 2006 as a non-profit organization to unite pharmaceutical and ...
(Date:12/8/2016)... ... 08, 2016 , ... Today’s patients are encouraged to be ... SIGVARIS has created a new line of anti-embolism stockings to help prevent a ... benefits of graduated compression when transitioning from recovery to early rehabilitation. , The ...
(Date:12/8/2016)... ... December 08, 2016 , ... The ... from offices headquartered in Hamilton County, is embarking on a charity drive with ... in finding new homes for orphaned or neglected senior dogs in the Cincinnati ...
(Date:12/8/2016)... (PRWEB) , ... December 08, 2016 , ... The Compretta ... commercial and residential clients in and around the Hancock County area, is announcing the ... Hancock County Food Pantry. , The Hancock County Food Pantry has worked for more ...
(Date:12/7/2016)... ... 07, 2016 , ... Students attending Envision’s summer 2017 ... get hands-on experience in an emergency medical simulation, When Care is Hours Away. ... real-life medical skills that are critical success in a future career and beyond. ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... Research and Markets has announced the addition of the ... Usability - Forecast to 2025" report to their offering. ... , , ... at a CAGR of around 3.2% from 2015 to 2025. Some ... in extracellular microelectrode arrays and intracellular microelectrodes, research in left-to-right shunt ...
(Date:12/8/2016)...   TriNetX , the health research network, ... signed a membership agreement to join the network ... cures. The TriNetX network is comprised ... globally, biopharmaceutical companies and contract research organizations (CROs) ... site selection, patient recruitment, and collaborative research across ...
(Date:12/8/2016)... Dec. 8, 2016  Pennsylvania Physician General Dr. ... and Alcohol Programs Gary Tennis released ... known as benzodiazepines, developed with the help of ... medications that are frequently prescribed for anxiety or ... used with opioid pain medications, benzodiazepines pose a ...
Breaking Medicine Technology: