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The following form is for your reference. Please repack the item carefully. 510(K) Number: K163414 Regulation Number: 872.4850 Product Code: ELC. This item is in the category "Business & Industrial\Healthcare, Lab & Dental\Handpieces & Instruments\Ultrasonic Scalers".The seller is "skyseashop" and is located in this country: US. This item can be shipped worldwide.