# K112024: TI-Max X450

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Jun 20, 2012 after 341 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). 11 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952927: Impact Air 45 4-Hole, Palisades Pharmaceutics, Inc. (1996) Summary page 1.
- K101717: Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor 45; Karam 4H Coupling, Aerobine, Inc. (2010) Summary page 1.

## Most influential descendants
- K130455: 430 SWL 45 and 430 SW 45 High-Speed Handpieces (2013), 9 descendants of its own
- K152146: High Speed Handpieces and Accessories (2015), 8 descendants of its own
- K170229: Dental High-speed Turbine Handpiece (2017), 4 descendants of its own
- K141576: Maxima PRO 45L (2015), 3 descendants of its own
- K181691: High-speed air turbine handpiece / Low-speed air turbine handpiece (2020), 2 descendants of its own

## Indications for use
The Ti Max X450 is an air-powered dental handpiece with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used The. Ti-Max X450 is intended for use with a friction grip bur that conforms to ISO 1797-1 standard. Recommended supply air pressure is between 0.22 and 0.30 MPa, which results in high 'speed bur rotation (approximately380,000 to 450,000 RPM):

Source page: https://510kreport.com/device/K112024
Methodology: https://510kreport.com/methodology