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 the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item.
The item has been cleaned and handled in accordance with 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
FDA for Portable Dental Unit: 510(K) Number: K111907, Regulation Number: 872.6640, Product Code: EIA
FDA for Autoclave Sterilizer: 510(K) Number: K231449, Regulation Number: 872.1800, Product Code: EHD
FDA for Endo Motor: 510(K) Number: K203320, Regulation Number: 872.4200, Product Code: EKX
FDA for Apex Locator: 510(K) Number: K181087, Product Code: LQY
Company name: Quanzhou Baian Information Technology Co., Ltd
City, State: Fujian, China
Telephone number: +08617302321053