Dallas, TX – (December 10, 2010) D4D Technologies, a leading manufacturer of dental CAD CAM systems, announced today that it has received ISO 13485 Certification, a Quality System Certificate indicating D4D has established and maintains a quality management system that meets worldwide standards for medical devices.
ISO 13485 was adopted in Europe in 1996 and is a modified version of ISO 9001 – but with additional requirements especially tailored for the medical device industry. Although ISO 13485 is voluntary, it is considered the "de facto" medical device standard.
D4D Technologies has also received an EC Certificate for the manufacture of the Dental Optical Impression System, indicating compliance with the European Medical Device Directive.
“We pursued certifications to these rigorous global standards so that our customers and their patients could have confidence that our products and services were of the highest quality and safety,” said Basil Haymann, founder and CEO of the company. “As D4D expands its product range and presence in markets around the world, the ISO 13485 certification is added assurance to partners and customers that D4D’s processes for product development, manufacturing, distribution, education, and customer support are of the highest caliber.”
About D4D Technologies LLC
D4D Technologies is taking the dental profession to a higher level of productivity, patient comfort, and convenience with its E4D Dentist™, E4D Labworks™ and E4D Studio™ Systems, all part of the E4D Sky™ Network of products. The systems use high-speed laser scanning technology to produce digital 3D impressions of teeth prepared for full contour crowns, inlays, onlays, smile designs, and no-prep veneers without the application of contrast agents. The intuitive DentaLogic™ software enables operators to customize restoration designs and send them wirelessly to the precision mill that uses the latest restorative materials to produce fine esthetic restorations.
Highly accurate, versatile, and easy to use, the E4D Systems provide significant productivity improvements allowing dental professionals to offer a healthier, more economical and more convenient solution with Same Day Dentistry™.
Headquartered in Richardson, TX, a suburb of Dallas, D4D Technologies has partnerships with major corporations in the dental profession: Henry Schein is the Company’s exclusive global distributor; 3M ESPE and Ivoclar Vivadent supply restorative materials.
