DESS Dental receives eighth and ninth FDA 510K clearances in the US

We are proud to announce that last week, DESS Dental received its 8th and 9th FDA (Food and Drug Administration) clearances for Medical Devices through 510K. The new approval expands the DESS® Dental cleared abutment system, one of the brands with the widest range of dental abutments, fully FDA compliant.

With the 8th and 9th clearances, the use has been extended to 30° angulation on pre-milled blanks for the following compatibilities: Nobel Active®, Zimmer®, Straumann® Bone Level, Nobel Replace SelectTM, Nobel Branemark®, Astra Tech® Evo, 3i® Certain, Astra Tech® Osseospeed. We have also increased the angulation to 30° for 3i® Certain, Zimmer® and Nobel® Replace Ti Bases.

This FDA certification reaffirms our commitment to manufacturing and commercialising the highest quality dental abutments and prosthetic solutions, meaning that our components are as safe and effective as legally marketed devices.

DESS® Dental prosthetic abutments are subject to the most rigorous quality controls, from design and manufacture to the testing, cleaning and packaging process. As a result, all our products and components are accredited by the strictest certifications worldwide: ISO 9001 and ISO 13485, FDA, CE, Health Canada and MDSAP, among others.

This success wouldn’t have been possible without our team’s hard work and effort! We are currently working to achieve our 10th 510K clearance from the FDA to expand more products and compatibilities.

Please remember the importance of keeping your libraries updated to the latest version to have the new references registered with the FDA. Here you can download the latest version of DESS® Dental CAD/CAM libraries for Exocad®, 3Shape®, and Dental Wings®.

For more information about certifications, lifetime warranty, or technical issues, don’t hesitate to contact us at or by phone at +34 937 198 995.