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Description 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 offer 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 Information
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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