# K230888: Titanium Turbine

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Jun 2, 2023 after 63 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: 8 generations back to K935676 (1995). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203791: Stainless Turbine, Nakanishi, Inc. (2022) Summary page 4.

## Indications for use
The Titanium 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).

Source page: https://510kreport.com/device/K230888
Methodology: https://510kreport.com/methodology