Statement: The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. If so, you can bid it on this item only if you are an authorized purchaser. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item. Seller name:Dentalbest City,State:SHENZHEN,China Telephone number:0755-7214638 Classification Name: FILE, PULP CANAL, ENDODONTICProduct Code: EKSDevice Class: 1Regulation Number: 872.4565Medical Specialty: Dental