If you have questions about legal obligations regarding sales of medical devices, you should consult with the FDA's Center for Devices and Radiological Health. This dental items is not meant to replace your doctor diagnostic. It is mainly for your piece of mind and comfort. This item is in the category "Business & Industrial\Healthcare, Lab & Dental\Medical, Lab & Dental Supplies\Orthodontic Brackets, Bands & Buccal Tubes".The seller is "chenjuan0226" and is located in this country: CN. This item can be shipped worldwide.