Import of Dental Devicesto USA - Compliance/Regulatory

We're interested in importing to USA dental fittings. Type of products: - Porcelaine Tooth (FDA ELL-872.3920) - Preformed plastic denture tooth (872.3590) HTS code: [login to view URL] / [login to view URL] Support needed is to understand which steps need to be followed with FDA and/or other regulatory entities in USA to import these type of dental fittings, to be ultimately sold to dentists. Hope this description is clear for the project.