T/GDMDMA 0003-2020 Customized Orthodontic Appliances
T/GDMDMA 0003-2020
Basic Information
Scope
This standard specifies the terms and definitions, classification, requirements, and test methods for customized orthodontic appliances (hereinafter referred to as orthodontic appliances). This standard applies to devices used in the treatment of malocclusion, which are manufactured using registered raw materials and consist of brackets, arch expanders, orthodontic wires, orthodontic base polymer, etc. These devices can directly generate force, or the functional force of masticatory muscles and perioral muscles can be transmitted through the appliance to cause changes in the malformed jawbone, misaligned teeth, and periodontal supporting tissues, thereby promoting the normal growth and development of the teeth and craniofacial region. This standard does not apply to fixed orthodontic appliances directly composed of accessories such as orthodontic wires, brackets, trays, or buccal tubes used by clinicians.