510(k) · Cleared
ClearedI-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 Nov 18, 2010 as substantially equivalent to K083901 (S-Denti Co., Ltd., 2009) after a 274-day review. Its family tree reaches back 1 generation to 2009. 3 later devices descend from it.
- Decided
- Nov 18, 2010
- Review
- 274 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K083901 (2009). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK083901 Navi RootS-Denti Co., Ltd. · 2009
- This deviceK100450 I-ROOTS-Denti Co., Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK112508 I-ROOT 100S-Denti Co., Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK210789 EQ-PEXMeta Systems Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK112153 Iroot 100 MiniS-Denti Co., Ltd. · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K083901 | Navi Root | S-Denti Co., Ltd. | 2009 | — |
| 0 (this device) | K100450 | I-ROOT | S-Denti Co., Ltd. | 2010 | — |
| +1 | K112508 | I-ROOT 100 | S-Denti Co., Ltd. | 2012 | — |
| +2 | K210789 | EQ-PEX | Meta Systems Co., Ltd. | 2021 | — |
| +1 | K112153 | Iroot 100 Mini | S-Denti Co., Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083901 | Navi RootSummary page 1…Name:. Root Apex Locator Ragulation Name: Root Apex Locator Regulatory Classification: Unclassified, Dental, Product Code: LQY C. Predicate device: Navi ROOT(K083901) D. Device Description The subject device is alightweight, fully-automatic, battery operated device that allows a dentist or ora… | 2009 |
What descends from it? (3)
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?
How does its category compare?
All LQY devicesLQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 i-ROOT is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100450: I-ROOT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100450
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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