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, do not bid on this item unless 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.
510(K) Number: K181691
Regulation Number: 872.4200
Classification Product Code: EFB
Subsequent Product Code: EGS
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
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