This dental items is not meant to replace your doctor diagnostic. It is mainly for your piece of mind and comfort.
Regulation Number: 21 CFR 872.6070. 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.