Custom-made mouthguard

Custom-made mouthguards are protective oral devices tailored to fit a patient’s teeth and gums precisely, designed to shield against dental trauma during contact sports or reduce damage from bruxism (teeth grinding). They act as a physical barrier between the upper and lower teeth, distributing impact forces and preventing fractures, dislocations, or soft tissue injuries.

These devices are typically regulated as medical devices due to their direct contact with oral tissues and functional purpose. They are often supplied by dental professionals or orthodontists, who create them from patient-specific impressions. Classification and supply pathways vary by jurisdiction, but they are generally considered reusable and require adherence to manufacturing standards for safety and effectiveness.