Custom-fabricated dental prosthetics — crowns, bridges, dentures, and orthodontic appliances — made to individual patient prescription in a dental laboratory are regulated by FDA as custom devices, generally exempt from premarket notification but still subject to establishment registration and adverse-event reporting requirements. Because these products are patient-specific, they present unique entry documentation challenges: commercial invoices must clearly identify the items as custom dental devices, and CBP may scrutinize valuation given the labor-intensive fabrication involved. Offshore dental laboratory work, particularly from China and other lower-cost manufacturing centers, has grown substantially, raising questions about quality-system oversight for foreign labs.

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