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The following form is for your reference. Please repack the item carefully. 510(K) Number: K181691 Regulation Number: 872.4200 Classification Product Code: EFB Subsequent Product Code: EGS. The item "Dental Portable Ultrasonic Piezo Scaler With 2 Water Bottles for Cavitron EMS EE1" is in sale since Thursday, December 29, 2016.This item is in the category "Business & Industrial\Healthcare, Lab & Dental\Handpieces & Instruments\Ultrasonic Scalers". The seller is "dentistskysea" and is located in Gresham, Oregon. This item can be shipped worldwide.