FDA distinguishes between custom devices — made for a specific patient based on a practitioner's order — and stock or catalog dental fittings. Custom dental devices may qualify for an exemption from standard 510(k) premarket notification requirements under FDA's custom device exemption, but strict conditions apply, including limitations on annual production volume. Importers and dental laboratories should review FDA's custom device guidance and consult a regulatory specialist to confirm the applicable pathway.

The primary material of the fitting body determines the line: acrylic or other plastic-based restorations fall under 9021294000, while porcelain, ceramic, zirconia, metal-ceramic, and other non-plastic fittings are classified under 9021298000. For composite or layered restorations, the essential character of the material — typically the structural substrate — governs classification. Clear material documentation from the dental laboratory is essential for accurate entry.