510(k) · Cleared
ClearedNavi Root
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S-Denti Co., Ltd. · LQY Locator, Root Apex
Cleared on Apr 15, 2009 after a 107-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Apr 15, 2009
- Review
- 107 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK083901 Navi RootS-Denti Co., Ltd. · 2009
- Descendant · cites it directly · 3 of its ownK100450 I-ROOTS-Denti Co., Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK151274 Dr's FinderGood Doctors Co., Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK112508 I-ROOT 100S-Denti Co., Ltd. · 2012
- Descendant · 3 generations on · 0 of its ownK210789 EQ-PEXMeta Systems Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK171867 Dr’s Finder NEOGood Doctors Co., Ltd. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K100450I-ROOTS-Denti Co., Ltd. · 2010 · cites it directly3descendants
- K151274Dr's FinderGood Doctors Co., Ltd. · 2016 · cites it directly1descendant
- K112508I-ROOT 100S-Denti Co., Ltd. · 2012 · 2 generations on1descendant
- K210789EQ-PEXMeta Systems Co., Ltd. · 2021 · 3 generations on0descendants
- K171867Dr’s Finder NEOGood Doctors Co., Ltd. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083901 | Navi Root | S-Denti Co., Ltd. | 2009 | — |
| +1 | K100450 | I-ROOT | S-Denti Co., Ltd. | 2010 | — |
| +1 | K151274 | Dr's Finder | Good Doctors Co., Ltd. | 2016 | — |
| +2 | K112508 | I-ROOT 100 | S-Denti Co., Ltd. | 2012 | — |
| +3 | K210789 | EQ-PEX | Meta Systems Co., Ltd. | 2021 | — |
| +2 | K171867 | Dr’s Finder NEO | Good Doctors Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LQY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LQY device
- #1 K252224 Apex Locator (FindPex)score 12.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K100450 (S-Denti Co., Ltd., 2010) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LQY devicesLQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LQY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LQY
164in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LQY
No recall names LQY since 2007.
Adverse event reports per year · LQY
51in 2025
MAUDE reports naming product code LQY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 15 |
| 2010 | 3 | 164 | 0 | 22 |
| 2011 | 2 | — | 0 | 140 |
| 2012 | 2 | — | 0 | 59 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 1 | — | 0 | 128 |
| 2017 | 0 | — | 0 | 133 |
| 2018 | 2 | — | 0 | 154 |
| 2019 | 1 | — | 0 | 163 |
| 2020 | 0 | — | 0 | 139 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 63 |
| 2023 | 1 | — | 0 | 56 |
| 2024 | 1 | — | 0 | 81 |
| 2025 | 2 | — | 0 | 51 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The NAVI ROOT is intended for measuring the length of the root
canal for the purpose of performing root canals.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K083901 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083901: Navi Root.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083901
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026