# K083901: Navi Root

- Pathway: 510(k) (Traditional)
- Applicant: S-Denti Co., Ltd.
- Decided: Apr 15, 2009 after 107 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K100450: I-ROOT (2010), 3 descendants of its own
- K151274: Dr's Finder (2016), 1 descendant of its own
- K112508: I-ROOT 100 (2012), 1 descendant of its own
- K210789: EQ-PEX (2021), 0 descendants of its own
- K171867: Dr’s Finder NEO (2018), 0 descendants of its own

## Indications for use
The NAVI ROOT is intended for measuring the length of the root canal for the purpose of performing root canals.

Source page: https://510kreport.com/device/K083901
Methodology: https://510kreport.com/methodology