# K960507: Star Dental Pushbutton Autochuck Replacement Turbine for Midwest Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Dentalez Group
- Decided: Mar 28, 1996 after 52 days
- Product code: EFA (Handpiece, Belt And/Or Gear Driven, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Midwest Quiet-Air and Tradition model handpieces: named in the summary without a submission number
- (no number) Star Dental 430 series pushbutton autochuck turbine: named in the summary without a submission number

## Recalls of this device
- Dec 1, 2006 · Not classified · Z-0313-2007: End cap component can disassemble.

## Indications for use
Both the predicate turbines and the proposed Star Dental replacement turbines are intended to be used as components to high speed handpieces, which are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings.

Source page: https://510kreport.com/device/K960507
Methodology: https://510kreport.com/methodology