FDA Statement:The sale of this item may be subject to regulation by the U. 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 "freshdent" and is located in this country: CN. This item can be shipped worldwide.