FDA Statement:

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

If so, you can bid on this item only if you are an authorized purchaser.

If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item.

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