NAMSA APEX Program™ Expedites 510(k) Clearance for Solvay Dental 360™, Delivers 12 Months & $7.5M in Development Savings

Solvay Specialty Polymers USA, LLC, a worldwide provider of biomaterials, is the leader in serving diversified markets around the globe. Traditionally, Solvay has been a supplier of biomaterials to the healthcare sector, but recently identified a significant market opportunity within the dental marketplace.

Recognizing a strong need for new and innovative materials within the denture sector, Solvay sought to accurately assess the market opportunity for a polymer solution while also evaluating the associated product development and commercialization requirements, timelines and costs.

To assist with the development of this novel device, Solvay required a clinical research organization (CRO) that possessed vast dental product expertise and also had deep-rooted experience in successfully navigating the U.S. Food & Drug Administration (FDA) 510(k) submission pathway for first-time market entrants.

We invite you to access this case study to learn how the NAMSA APEX Program delivered Solvay 12 months and $7.5M in 510(k) development savings.

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