# K201192: Impla-NX (Model: ISE-270M)

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Nx Co., Ltd.
- Decided: May 21, 2021 after 382 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: 4 generations back to K002469 (2001). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173905: Surgic Pro, Surgic Pro+, Nakanishi, Inc. (2018) Summary page 4.

## Most influential descendants
- K231562: ELEC ENGINE (Model: ISE-170L) (2025), 0 descendants of its own

## Indications for use
The Impla-NX (Model: ISE-270M) is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

Source page: https://510kreport.com/device/K201192
Methodology: https://510kreport.com/methodology