C5 Medical Werks receives FDA clearance, CE certification for advanced ZirDent ceramic CAD/CAM Blocks

DENVER, Colorado--C5 Medical Werks, a manufacturer of ceramic solutions for the medical device industry, has received clearance from the U.S. Food and Drug Administration to market the company's ZirDent 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 CAD/CAM Blocks are available in an unlimited variety of shapes, sizes and sintering options--presintered, fully sintered and HIP'd--to meet each customer's unique specifications. In a 510(k) clearance letter, the FDA found ZirDent 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 from the British Standards Institute, allowing the marketing of the product in Europe. The Conformite Europeene marking process ensures the medical device meets the European Union and European Free Trade Association health, safety and environmental standards for consumer safety.

"Achieving compliance and meeting the exacting standards required for the medical marketing of ZirDent in the United States and Europe is a major milestone for us," said Andrew Nield, director of sales and marketing for C5 Medical Werks.

For more information, visit C5 Medical Werks or call (877) 259-3757.

To read more about C5 Medical Werks, go to C5 Medical Werks.

To comment on this subject, go to PennWell Dental Community site.