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 eighth and ninth 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 Select®, 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 commercializing 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 tenth 510K clearance from the FDA to expand more products and compatibilities.
Please remember the importance of keeping your libraries updated with 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®.