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The sale of this item may be subject to regulation by the U.S. Food & Drug Administration and state and local regulatory agencies.You can offer on this item if you are an authorized purchaser. If the item is subject to FDA regulation, We will verify your status as an authorized purchaser of this item before shipping of the item.If you have questions about legal obligations regarding sales of medical devices, you should consult with the FDA\'s Center for Devices and Radiological Health.
(This dental items is not meant to replace your doctor diagnostic. It is mainly for your piece of mind and comfort.)
510(K) Number: K181691Regulation Number: 872.4200Classification Product Code: EFBSubsequent Product Code: EGS
