SEASKY Dental Electric Ultrasonic scaler for EMS Tips E3/ Handpiece 135°C USA

FDA for Scaler: 510(K) Number: K163414, Regulation Number: 872.4850, Product Code: ELC. FDA for Handpiece: 510(K) Number: K181691, Regulation Number: 872.4200, Classification Product Code: EFB, Subsequent Product Code: EGS.