# K233288: NLZ Built-In Motor System

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Jun 24, 2024 after 269 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- 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: 6 generations back to K983183 (1998). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181858: Electric Handpiece Motor, W&H Dentalwerk Buermoos GmbH (2019) Summary page 5.
- K161213: XSmart iQ, Dentsply Sirona (2017) Summary page 5.

## Indications for use
The NLZ Built-in Motor System is indicated for use in the field of prophylaxis dentistry, restorative applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.

Source page: https://510kreport.com/device/K233288
Methodology: https://510kreport.com/methodology