Food and Drug Administration and state and local regulatory agencies. If you have any query or dissatisfaction, please. Wish you have a nice day! This item is in the category "Business & Industrial\Healthcare, Lab & Dental\Medical, Lab & Dental Supplies\Orthodontic Brackets, Bands & Buccal Tubes". The seller is "dentex2019" and is located in this country: CN.This item can be shipped worldwide.