# K100450: I-ROOT

- Pathway: 510(k) (Traditional)
- Applicant: S-Denti Co., Ltd.
- Decided: Nov 18, 2010 after 274 days
- Product code: LQY (Locator, Root Apex)
- Device class: U
- 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 K083901 (2009). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083901: Navi Root, S-Denti Co., Ltd. (2009) Summary page 1.

## Most influential descendants
- K112508: I-ROOT 100 (2012), 1 descendant of its own
- K210789: EQ-PEX (2021), 0 descendants of its own
- K112153: Iroot 100 Mini (2012), 0 descendants of its own

## Indications for use
The i-ROOT is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures

Source page: https://510kreport.com/device/K100450
Methodology: https://510kreport.com/methodology