Yes. Dental impression materials and waxes intended for clinical use are classified as medical devices under FDA jurisdiction. Foreign manufacturers must be registered with FDA, and the products must comply with applicable device regulations, including quality system requirements. Importers should ensure that entry documentation identifies the intended dental use to avoid misclassification.

The key distinction is intended end use: dental impression compounds are specifically formulated and labeled for clinical dental procedures and fall under FDA device oversight, while general modelling pastes (e.g., for arts and crafts) do not. Packaging, labeling, and accompanying documentation should clearly reflect the intended application, as customs authorities may request evidence of end use to confirm the correct classification.