Orthodontic Splints as Biomedical Devices: Indications, Fabrication Techniques, and Clinical Applications

Orthodontic splints, traditionally regarded as adjunctive appliances for retention or occlusal stabilization, remain paradoxically under-theorized as biomedical devices despite their ubiquity in clinical practice. This study addresses this critical gap by reframing splints through biomedical engineering, regulatory science, and translational healthcare.