510(k) Report

510(k) · Cleared

Cleared

Apex Locator Bingo-1020

K992233510(k) TraditionalCleared Nov 30, 1999158-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dent Corp. Research & Development · LQY Locator, Root Apex

Cleared on Nov 30, 1999 after a 158-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 13 later devices descend from it.

Decided
Nov 30, 1999
Review
158 days
Class
Class U
Product code
LQY
Recalls
None
Predicates
0

13 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant cleared2018: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant cleared2025: 2 descendants cleared1995200020052010201520202025
  1. This deviceK992233 Apex Locator Bingo-1020Dent Corp. Research & Development · 1999
  2. Descendant · cites it directly · 11 of its ownK111474 Bingo ProForum Engineering Technologies (96), Ltd. · 2011
  3. Descendant · 2 generations on · 9 of its ownK131907 Raypex 6Dentsply International, Inc. · 2014
  4. Descendant · 3 generations on · 5 of its ownK191806 Propex IQ Apex LocatorDentsply Sirona · 2019
  5. Descendant · 4 generations on · 4 of its ownK203836 BOMEDENT Apex locator, WISMY Apex locatorChangzhou Bomedent Medical Technology Co.,Ltd · 2021
  6. Descendant · 3 generations on · 2 of its ownK181087 Apex Locator, DPEX IIIGuilin Woodpecker Medical Instrument Co., Ltd. · 2018

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12013: 12014: 12018: 12019: 12021: 12022: 12023: 12024: 12025: 22026: 1
2010high 2 (2025) · low 0 (2012)2026

Most influential descendants

Showing 5 of 13 · See all
  • K111474Bingo ProForum Engineering Technologies (96), Ltd. · 2011 · cites it directly11descendants
  • K131907Raypex 6Dentsply International, Inc. · 2014 · 2 generations on9descendants
  • K191806Propex IQ Apex LocatorDentsply Sirona · 2019 · 3 generations on5descendants
  • K203836BOMEDENT Apex locator, WISMY Apex locatorChangzhou Bomedent Medical Technology Co.,Ltd · 2021 · 4 generations on4descendants
  • K181087Apex Locator, DPEX IIIGuilin Woodpecker Medical Instrument Co., Ltd. · 2018 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K992233Apex Locator Bingo-1020Dent Corp. Research & Development1999—
+1K111474Bingo ProForum Engineering Technologies (96), Ltd.2011—
+2K131907Raypex 6Dentsply International, Inc.2014—
+3K191806Propex IQ Apex LocatorDentsply Sirona2019—
+4K203836BOMEDENT Apex locator, WISMY Apex locatorChangzhou Bomedent Medical Technology Co.,Ltd2021—
+3K181087Apex Locator, DPEX IIIGuilin Woodpecker Medical Instrument Co., Ltd.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201310
201410
201810
201910
202110
202210
202310
202410
202520
202610
FIG. 1 — Lineage of K992233, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252224 Apex Locator (FindPex)score 12.0 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (13)

See all 13

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111474Bingo ProForum Engineering Technologies (96), Ltd.201111
K101054Romiapex Model a-15Romidan, Ltd.20100

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, K111474 (Forum Engineering Technologies (96), Ltd., 2011) has gone furthest, with 11 descendants of its own.

How does its category compare?

All LQY devices

LQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LQY

2in 2025

2007: 22008: 22009: 22010: 32011: 22012: 22013: 12014: 12016: 12018: 22019: 12021: 22022: 12023: 12024: 12025: 22026 (partial year): 1
2007high 3 (2010) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LQY

164in 2010

2010: 164 days median
2007high 164 (2010)2026

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

2008: 12009: 152010: 222011: 1402012: 592013: 22015: 592016: 1282017: 1332018: 1542019: 1632020: 1392021: 1072022: 632023: 562024: 812025: 51
2007high 163 (2019) · low 0 (2007)2025

MAUDE reports naming product code LQY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20082—01
20092—015
20103164022
20112—0140
20122—059
20131—02
20141—00
20150—059
20161—0128
20170—0133
20182—0154
20191—0163
20200—0139
20212—0107
20221—063
20231—056
20241—081
20252—051
20261—0—

What is it indicated for?

BINGO-1020 is a modern device for precise apex localization during root channel treatment.

BINGO-1020 is distinguished by increasing precision at 0.1mm on wet/dry, large graphic display where current position of endo file is reflected and other essential information is displayed.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K992233: Apex Locator Bingo-1020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992233

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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