K100389 - HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT
(FDA 510(k) Clearance)

K100389 is an FDA 510(k) clearance for the HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT. This device is classified as a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB).

Submitted by Handpiece Headquarters (Placentia, US). The FDA issued a Cleared decision on August 12, 2010, 177 days after receiving the submission on February 16, 2010.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.