Seventh 510K FDA clearance for DESS® prosthetic abutments in the USA

We are proud to announce the seventh FDA clearance (New K212628) for our Ti Bases and abutments in the USA, reaffirming our commitment to manufacturing and commercialising the highest quality prosthetic products and solutions.

The FDA (Food and Drug Administration) is one of the highest demanding regulatory departments in the United States. An agency of the Department of Health and Human Services that requires FDA registration as a basic requirement for all domestic and foreign establishments that manufacture or market food, drugs, API or medical devices in the United States, and for their products not classified as exempt medical devices.

At DESS^® Dental we have the widest range of prosthetic abutments that are fully FDA compliant. We work under the strictest quality standards and regulatory requirements in reference territories (CE, MDSAP, Health Canada, ISO 9001, ISO 13485, Japan and FDA) to offer our customers a unique product, with a lifetime warranty, distinguished by its constant innovation and functionality. DESS^® will soon submit for PNP clearance, which will allow a much higher degree of freedom for our end-users.

In this regard, it is important to keep the libraries updated to the latest version to have the new references registered with the FDA. In this link, you can download the latest version of DESS^® Dental's free CAD/CAM libraries for Exocad^®, 3Shape^®, and Dental Wings^®.

For more information, please don’t hesitate to contact our technical support team by sending an email to info@dessdental.com or by calling telephone +34 937 198 995.

*For United States users where the usage restrictions are specified, please check the IFU at this link.