510(k) · Cleared
ClearedBingo Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Forum Engineering Technologies (96), Ltd. · LQY Locator, Root Apex
Cleared on Nov 2, 2011 as substantially equivalent to K992233 (Dent Corp. Research & Development, 1999) after a 159-day review. Its family tree reaches back 1 generation to 1999. 11 later devices descend from it.
- Decided
- Nov 2, 2011
- Review
- 159 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992233 (1999). 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK992233 Apex Locator Bingo-1020Dent Corp. Research & Development · 1999
- This deviceK111474 Bingo ProForum Engineering Technologies (96), Ltd. · 2011
- Descendant · cites it directly · 9 of its ownK131907 Raypex 6Dentsply International, Inc. · 2014
- Descendant · 2 generations on · 5 of its ownK191806 Propex IQ Apex LocatorDentsply Sirona · 2019
- Descendant · 3 generations on · 4 of its ownK203836 BOMEDENT Apex locator, WISMY Apex locatorChangzhou Bomedent Medical Technology Co.,Ltd · 2021
- Descendant · 2 generations on · 2 of its ownK181087 Apex Locator, DPEX IIIGuilin Woodpecker Medical Instrument Co., Ltd. · 2018
- Descendant · 4 generations on · 1 of its ownK232717 Apex Locator (AL-Pex), Apex Locator (AL-Pex+)Changzhou Haili Medical Co., Ltd. · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K131907Raypex 6Dentsply International, Inc. · 2014 · cites it directly9descendants
- K191806Propex IQ Apex LocatorDentsply Sirona · 2019 · 2 generations on5descendants
- K203836BOMEDENT Apex locator, WISMY Apex locatorChangzhou Bomedent Medical Technology Co.,Ltd · 2021 · 3 generations on4descendants
- K181087Apex Locator, DPEX IIIGuilin Woodpecker Medical Instrument Co., Ltd. · 2018 · 2 generations on2descendants
- K232717Apex Locator (AL-Pex), Apex Locator (AL-Pex+)Changzhou Haili Medical Co., Ltd. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992233 | Apex Locator Bingo-1020 | Dent Corp. Research & Development | 1999 | — |
| 0 (this device) | K111474 | Bingo Pro | Forum Engineering Technologies (96), Ltd. | 2011 | — |
| +1 | K131907 | Raypex 6 | Dentsply International, Inc. | 2014 | — |
| +2 | K191806 | Propex IQ Apex Locator | Dentsply Sirona | 2019 | — |
| +3 | K203836 | BOMEDENT Apex locator, WISMY Apex locator | Changzhou Bomedent Medical Technology Co.,Ltd | 2021 | — |
| +2 | K181087 | Apex Locator, DPEX III | Guilin Woodpecker Medical Instrument Co., Ltd. | 2018 | — |
| +4 | K232717 | Apex Locator (AL-Pex), Apex Locator (AL-Pex+) | Changzhou Haili Medical Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K992233 | Apex Locator Bingo-1020Summary page 6…ts. 5.8. Conclusions: [ 807.92(b)(3)] * BINGO PRO has the same intended use and fundamental scientific technology as its predicate device - Bingo- 1020 (K992233). " BINGO PRO was evaluated against its predicate device, and was found to be Substantially Equivalent. 5-H3… | 1999 |
What descends from it? (11)
See all 112 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. 2011, 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?
BINGO PRO is an electronic device used for precise apex localization and working length determination during root canal treatment. The device enables to obtain correct results in canals with different conditions - dry or wet.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111474 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111474: Bingo Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111474
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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