Item Tag: AZDENT

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 bid 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. Seller name: dentalbravo City,State:SHENZHEN,China Telephone number:0755-61295575 Re: K181691Trade/Device Name: High-speed air turbine handpiece / Low-speed air turbine handpieceRegulation Number: 21 CFR 872.4200Regulation Name: Dental Handpiece and AccessoriesRegulatory Class: Class I, reservedProduct Code: EFB, EGSDated: April 9, 2020Received: April 27, 2020Proprietary Name: BUR,DENTAL Classification Name: BUR,DENTAL Product Code: EJLDevice Class:1Regulation Number:8723240Medical Specialty:DentalRegistered Establishment Number: 3009768364Owner/Operator Number: 10051861K181691Trade/Device Name: High-speed air turbine handpiece / Low-speed air turbine handpieceRegulation Number: 21 CFR 872.4200Regulation Name: Dental Handpiece and AccessoriesRegulatory Class: Class I, reservedProduct Code: EFB, EGSDated: April 9, 2020Received: April 27, 2020Classification Name: BUR, DENTALProduct Code: EJLDevice Class: 1Regulation Number: 872.324Medical Specialty: Dental