FDA for Handpiece: 510(K) Number: K181691, Regulation Number: 872.4200, Classification Product Code: EFB, Subsequent Product Code: EGS. FDA for Scaler: 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 "dentaloem" and is located in this country: US. This item can be shipped worldwide.