C5 Medical’s ZirDent CAD/CAM Blocks are available in an unlimited variety of shapes, sizes and sintering options – pre-sintered, fully sintered and HIP’d – to meet each customer’s unique specifications. In their 510(k) clearance letter, the FDA found ZirDent dental blocks to be substantially equivalent to competitive zirconia ceramic blocks currently sold to the US dental profession.
According to the company, 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.
Additionally, the company has received CE certification for ZirDent from the British Standards Institute, allowing the marketing of the product in Europe.
Andrew Nield, director of sales and marketing at C5 Medical, said: Achieving compliance and meeting the exacting standards required for the medical marketing of ZirDent in the US and Europe is a major milestone for us.