# K113655: TI-Max X Turbine

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Mar 5, 2012 after 84 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: 5 generations back to K935676 (1995). 12 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102517: Tiger 500 Series High Speed Handpieces and Attachments, Thunder Tiger Corp. (2011) Summary page 1.

## Most influential descendants
- K131319: T1/T2/T3 Turbine Family (2014), 2 descendants of its own
- K203791: Stainless Turbine (2022), 1 descendant of its own
- K230888: Titanium Turbine (2023), 0 descendants of its own

## Indications for use
The Ti-Max X Turbine Series is an air-powered dental handpiece intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

Source page: https://510kreport.com/device/K113655
Methodology: https://510kreport.com/methodology