FDA for Curing Light: 510(K) Number: K192233, Regulation Number: 21 CFR 872.6070, Product Code: EBZ. 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\Medical & Lab Equipment, Devices\Ultrasonic Cleaners". The seller is "jinlan226" and is located in this country: CN.This item can be shipped to North, South, or Latin America, all countries in Europe, all countries in continental Asia, Australia.