510(k) · Cleared
ClearedElectronic Apex Locator (Alpha Apex I)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Superline Technology CO., LTD. · LQY Locator, Root Apex
Cleared on Jan 17, 2025 as substantially equivalent to K232717 (Changzhou Haili Medical Co., Ltd., 2023) after a 126-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Jan 17, 2025
- Review
- 126 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K992233 (1999). No later device cites it as a predicate yet.
- Root · 6 generations backK992233 Apex Locator Bingo-1020Dent Corp. Research & Development · 1999
- 5 generations backK111474 Bingo ProForum Engineering Technologies (96), Ltd. · 2011
- 4 generations backK131907 Raypex 6Dentsply International, Inc. · 2014
- 3 generations backK191806 Propex IQ Apex LocatorDentsply Sirona · 2019
- 2 generations backK203836 BOMEDENT Apex locator, WISMY Apex locatorChangzhou Bomedent Medical Technology Co.,Ltd · 2021
- 1 generation backK232717 Apex Locator (AL-Pex), Apex Locator (AL-Pex+)Changzhou Haili Medical Co., Ltd. · 2023
- This deviceK242765 Electronic Apex Locator (Alpha Apex I)Shenzhen Superline Technology CO., LTD. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K992233 | Apex Locator Bingo-1020 | Dent Corp. Research & Development | 1999 | — |
| −5 | K111474 | Bingo Pro | Forum Engineering Technologies (96), Ltd. | 2011 | — |
| −4 | K131907 | Raypex 6 | Dentsply International, Inc. | 2014 | — |
| −3 | K191806 | Propex IQ Apex Locator | Dentsply Sirona | 2019 | — |
| −2 | K203836 | BOMEDENT Apex locator, WISMY Apex locator | Changzhou Bomedent Medical Technology Co.,Ltd | 2021 | — |
| −1 | K232717 | Apex Locator (AL-Pex), Apex Locator (AL-Pex+) | Changzhou Haili Medical Co., Ltd. | 2023 | — |
| 0 (this device) | K242765 | Electronic Apex Locator (Alpha Apex I) | Shenzhen Superline Technology CO., LTD. | 2025 | — |
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 |
|---|---|---|---|
| * | K232717 | Apex Locator (AL-Pex), Apex Locator (AL-Pex+)Summary page 5…mon Name: Root Apex Locator Classification: Unclassified Product Code: LQY III. Predicate and Reference Devices Primary Predicate: Apex Locator (AL-Pex+) 510(k) number: K232717 Common Name: Root Apex Locator Classification: Unclassified Product Code: LQY IV. Indications for Use The Electronic Apex Locat… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All LQY devicesLQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Electronic Apex Locator is used to support the dentist in the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242765 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242765: Electronic Apex Locator (Alpha Apex I).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242765
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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