Custom-made dental anatomy model

A custom-made dental anatomy model is a patient-specific replica of teeth and gums, typically made from gypsum-based materials like plaster or dental stone. It is created by taking an impression of the patient’s oral structures, pouring the material into the mold, and allowing it to set, resulting in a physical model used to plan or guide dental treatments such as restorations or orthodontic appliances.

This category of device is intended for single use and is produced individually for each patient based on their unique anatomy. As a custom-made device, it is not mass-produced and falls under specific regulatory pathways for patient-specific products, which may vary by jurisdiction but generally involve documentation of the manufacturing process and conformity with essential safety and performance requirements.