510(k) K100389

HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT by Handpiece Headquarters — Product Code EFB

K100389 is an FDA 510(k) premarket notification submitted by Handpiece Headquarters for the device "HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT". The FDA issued a decision of Substantially Equivalent on August 12, 2010. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Handpiece Headquarters has at least 5 other 510(k) clearances on record.