FDA distinguishes between prefabricated dental devices (subject to standard device registration and clearance requirements) and custom-fabricated dental prosthetics made to an individual patient's prescription. Custom devices may qualify for an exemption from premarket notification requirements, but the foreign dental laboratory must still be registered with FDA and comply with applicable quality system regulations. Importers should document the custom nature of the order and the prescribing dentist's information to support this classification.

Imported artificial teeth are most commonly fabricated from acrylic resin (PMMA) or porcelain, with newer composite and zirconia materials growing in use. Material composition does not change the SITC heading classification, but it can affect HTS subheading allocation and may be relevant to FDA device standards, since different materials are subject to different biocompatibility and performance requirements.