For Cavitron Dental Ultrasonic Scaler SKYSEA fit EMS Handpiece Tip+2 Bottles FDA. 510(K) Number: K163414 Regulation Number: 872.4850 Product Code: ELC. The sale of this item may be subject to regulation by the U. Food and Drug Administration and state and local regulatory agencies. IMPORTANT INFORMATION ON OUR POLICY AND FEEDBACK. Feedback if you are satisfied with our items. We try to be fair and accurate with all of our product listings and descriptions. If there is a problem, we can work together to resolve it. We strive to always be extremely fair and always try to work with reasonable customers. We will always make every attempt possible to resolve issues if we made a mistake. Please do not assume a mistake is intentional. Let us know if our service could be better! Tracking info of your parcel is available. The following form is for your reference. Please repack the item carefully.