# K203791: Stainless Turbine

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Jun 21, 2022 after 540 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: 7 generations back to K935676 (1995). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131319: T1/T2/T3 Turbine Family, Sirona Dental Systems GmbH (2014) Summary page 4.
- K112024: TI-Max X450, Nakanishi, Inc. (2012) Summary page 4.

## Most influential descendants
- K230888: Titanium Turbine (2023), 0 descendants of its own

## Indications for use
The Stainless Turbine is intended for the following applications: Caries removal, Cavity and crown preparation, Removal of dental restorations (fillings and prostheses), Finishing of teeth and dental restorations (preparation/adjustment). The coupling is intended for the following applications: A connection device to transfer energy (air, water, light) required for handpieces.

Source page: https://510kreport.com/device/K203791
Methodology: https://510kreport.com/methodology