The sale of this item may be subject to regulation by the U. Food and Drug Administration and state and local regulatory agencies. 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.