6 Simple Steps for FDA Validation

More and more labs are choosing to mill in-house for convenience and efficiency. However, many hesitate to take the leap due to the cost, paperwork and processes required to achieve FDA validation. By using DESS® PNP FDA-accredited Premilled Blanks and Ti-Bases and Axsys Dental Solutions Versamill® Dental Milling Machines, Milling Centers and Dental Laboratories can ensure their final products are automatically FDA compliant. Now, there’s a way to become FDA-validated in a few simple steps.

Step 1: FDA-Approved Product
Use any FDA-approved DESS implant component or premill blank. These components meet the necessary regulatory standards, providing a solid foundation for compliance.

Step 2: Scanning
Utilize a 3shape lab scanner or a Medit intraoral scanner to create precise digital impressions. These tools are integral to ensuring accurate and FDA-compliant results.

Step 3: Download
Download and install DESS FDA PNP-approved libraries. These libraries are essential for integrating validated workflows into your milling process.

Step 4: CAD Design
Design custom premilled abutments or zirconia superstructures using 3shape or exocad software. These advanced CAD tools enable precise and FDA-compliant designs.

Step 5: CAM + Milling
Calculate the toolpath using hyperDENT software and produce components on Versamill milling machines. Ensure you use validated zirconia discs to meet FDA standards.

Step 6: Bonding
Cement the structure using validated bonding products. Proper bonding ensures the integrity and compliance of your final product.

Ready to Mill In-House?
By following this 6-step recipe, FDA validation is automatic, and you’ll be ready to mill in-house in no time. The DESS PNP workflow simplifies the process, eliminates paperwork headaches, and ensures regulatory compliance.

Learn more.
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