Dental Equipment & Supplies

Dental restorative materials such as amalgam and composite resins are regulated as Class II medical devices by FDA, typically requiring 510(k) clearance. Some materials with drug-like components may be reviewed as combination products. Importers should verify the product's FDA classification and clearance status, as well as any applicable EPA regulations on mercury content for amalgam products.

Dental equipment and supplies (NAICS 339114) covers instruments and materials used chairside by dental practitioners — handpieces, curing lights, impression trays, and consumables. Dental laboratory products (NAICS 339116) covers custom-fabricated items made to patient specification in a lab setting, such as crowns, bridges, and dentures. The distinction affects both HTS classification and FDA regulatory pathway, since lab-fabricated prosthetics are often custom devices with different clearance requirements.