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:2/13/2016)... ... 2016 , ... Hidden Cypress in Sun City is the place to be on March 3rd ... Frederick Weniger will be hosting this educational seminar from 5:30 p.m. – 7:00 p.m. ... special pricing on offers. In addition, prizes will be given away and light refreshments will ...
(Date:2/13/2016)... ... ... individuals looking to lead a healthy lifestyle have decreased carbohydrate consumption and increased their ... delved into this niche allowing those giving up their beloved pasta a chance to ... of protein and only 7 grams of carbohydrates per 50 gram serving--a ratio that ...
(Date:2/13/2016)... Tennessee (PRWEB) , ... February 13, 2016 , ... ... the Infusion Nurses Society (INS) states that vein visualization technology should be used ... by healthcare facilities around the world, the INS Standards mandate the use of ...
(Date:2/13/2016)... ... , ... In the early or “honeymoon” stage of a relationship, couples strive ... their way to be romantic, and may exaggerate a strength or two in an ... profile. , A recent study from Queendom.com , however, suggests that new ...
(Date:2/12/2016)... Antonio, TX (PRWEB) , ... February 12, 2016 , ... ... love, as expressed in Blue SKies Buddha, the biography of Rama - Dr. Frederick ... fact a love story, the love of a Buddhist teacher for teaching and helping ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... IRVINE, Calif., Feb. 11, 2016 PRO-DEX, INC. (NasdaqCM: ... quarter ended December 31, 2015. The Company also filed its ... fiscal year 2016 with the Securities and Exchange Commission today. ... December 31, 2015 --> --> ... 2015 increased $2.6 million, or 95%, to $5.4 million from ...
(Date:2/11/2016)... , Feb. 11, 2016   Health 2.0 , ... new health technologies, announced today " 10 Year Global ... health tech over the past ten years.   ... a decade, Health 2.0 has served as the preeminent ... connected with thousands of technologies, companies, innovators, and patient-activists ...
(Date:2/11/2016)... , Feb. 11, 2016  AfterPill.com is reporting that ... alcohol abstinence for all women who are at risk ... U.S. each year and raises the risks of unprotected ... --> According to the Guttmacher Institute, there ... women of child-bearing age, who have sex without the ...
Breaking Medicine Technology: