510(k) · Cleared
ClearedRaypex 6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International, Inc. · LQY Locator, Root Apex
Cleared on Jan 31, 2014 as substantially equivalent to K111474 (Forum Engineering Technologies (96), Ltd., 2011) after a 219-day review. Its family tree reaches back 2 generations to 1999. 9 later devices descend from it.
- Decided
- Jan 31, 2014
- Review
- 219 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992233 (1999). 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK992233 Apex Locator Bingo-1020Dent Corp. Research & Development · 1999
- 1 generation backK111474 Bingo ProForum Engineering Technologies (96), Ltd. · 2011
- This deviceK131907 Raypex 6Dentsply International, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK191806 Propex IQ Apex LocatorDentsply Sirona · 2019
- Descendant · 2 generations on · 4 of its ownK203836 BOMEDENT Apex locator, WISMY Apex locatorChangzhou Bomedent Medical Technology Co.,Ltd · 2021
- Descendant · cites it directly · 2 of its ownK181087 Apex Locator, DPEX IIIGuilin Woodpecker Medical Instrument Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK232717 Apex Locator (AL-Pex), Apex Locator (AL-Pex+)Changzhou Haili Medical Co., Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK212178 Root Apex LocatorFoshan Coxo Medical Instrument Co., Ltd. · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K191806Propex IQ Apex LocatorDentsply Sirona · 2019 · cites it directly5descendants
- K203836BOMEDENT Apex locator, WISMY Apex locatorChangzhou Bomedent Medical Technology Co.,Ltd · 2021 · 2 generations on4descendants
- K181087Apex Locator, DPEX IIIGuilin Woodpecker Medical Instrument Co., Ltd. · 2018 · cites it directly2descendants
- K232717Apex Locator (AL-Pex), Apex Locator (AL-Pex+)Changzhou Haili Medical Co., Ltd. · 2023 · 3 generations on1descendant
- K212178Root Apex LocatorFoshan Coxo Medical Instrument Co., Ltd. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992233 | Apex Locator Bingo-1020 | Dent Corp. Research & Development | 1999 | — |
| −1 | K111474 | Bingo Pro | Forum Engineering Technologies (96), Ltd. | 2011 | — |
| 0 (this device) | K131907 | Raypex 6 | Dentsply International, Inc. | 2014 | — |
| +1 | K191806 | Propex IQ Apex Locator | Dentsply Sirona | 2019 | — |
| +2 | K203836 | BOMEDENT Apex locator, WISMY Apex locator | Changzhou Bomedent Medical Technology Co.,Ltd | 2021 | — |
| +1 | K181087 | Apex Locator, DPEX III | Guilin Woodpecker Medical Instrument Co., Ltd. | 2018 | — |
| +3 | K232717 | Apex Locator (AL-Pex), Apex Locator (AL-Pex+) | Changzhou Haili Medical Co., Ltd. | 2023 | — |
| +3 | K212178 | Root Apex Locator | Foshan Coxo Medical Instrument Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K111474 | Bingo ProSummary page 2…Proposed Device BINGO PRO RAYPEX® 6 510(k) K 111474 Pending Device Definition Electronic apex locator Electronic apex locator… | 2011 |
What descends from it? (9)
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 11.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K191806 (Dentsply Sirona, 2019) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K111474.
How does its category compare?
All LQY devicesLQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
RAYPEX® 6 is a microprocessor controlled device used for locating the apex.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131907 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131907: Raypex 6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131907
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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