The sale of this item may be subject to regulation by the U. Food & Drug Administration and state and local regulatory agencies.
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: K181691 Regulation Number: 872.4200 Classification Product Code: EFB Subsequent Product Code: EGS. Regulation Number: 21 CFR 872.6070.