Autoclavable, the box can also be sterilized. 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.