# K112508: I-ROOT 100

- Pathway: 510(k) (Traditional)
- Applicant: S-Denti Co., Ltd.
- Decided: Jun 19, 2012 after 294 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: 2 generations back to K083901 (2009). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100450: I-ROOT, S-Denti Co., Ltd. (2010) Summary page 1.

## Most influential descendants
- K210789: EQ-PEX (2021), 0 descendants of its own

## Indications for use
The i-ROOT 100 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/K112508
Methodology: https://510kreport.com/methodology