# K100389: HHC Push-Button Replacement Turbine for Midwest Tradition Handpiece Model MW Turbine Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Handpiece Headquarters
- Decided: Aug 12, 2010 after 177 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971774 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971774: NSK Push-Button Midwest Replacement Turbine:for Quietair and Tradition, Nsk Nakanishi, Inc. (1997) Summary page 1.

## Indications for use
This HHC-Push button air turbine is intended for use with the Midwest Tradition Handpiece in replacement of Midwest Tradition's original turbine. The Dental Handpiece with the HHC- replacement turbine is used by authorized persons in the practice of dentistry. The H-HC-replacement turbine is used in the Midwest Tradition High Speed Dental Handpiece, which is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.

Source page: https://510kreport.com/device/K100389
Methodology: https://510kreport.com/methodology