# K121901: TI-Max Z45

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Feb 28, 2013 after 244 days
- Product code: EGS (Handpiece, Contra- And Right-Angle Attachment, 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: 1 generation back to K011061 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070663: A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97,  a-Dec/W&H Synea Handpiece Attachment, A-Dec, Inc. (2007) Summary page 2.
- K011061: Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight Handpieces Types, S-9, S-10, S-11, W&H Dentalwerk Buermoos GmbH (2001) Summary page 3.

## Indications for use
Ti-MAx Z45 is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, toot and crown preparations, finishing and trimming teeth and filling materials, and removal of crowns and filling materials.

Source page: https://510kreport.com/device/K121901
Methodology: https://510kreport.com/methodology