About US
Company name: Quanzhou Baian Information Technology Co., Ltd
City, State: Fujian, China
Telephone number: 0591-51485269
The following FDA Disclaimer is required.
REFERENCE:
Statement: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 bid 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.)
This item has been cleaned and treated according to the manufacturer's instructions.
FDA for Curing Light: 510(K) Number: K080025, Regulation Number: 21 CFR 872.6070, Product Code: EBZ
FDA for Handpiece: 510(K) Number: K181900, Regulation Number: 872.4200, Classification Product Code: EFB
FDA for Scaler: 510(K) Number: K053555, Regulation Number: 872.4850, Product Code: ELC