510(k) Report

510(k) · Cleared

Cleared

Dr's Finder

K151274510(k) TraditionalCleared Feb 4, 2016267-day reviewClass U

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

Good Doctors Co., Ltd. · LQY Locator, Root Apex

Cleared on Feb 4, 2016 as substantially equivalent to K083901 (S-Denti Co., Ltd., 2009) and 1 other predicate after a 267-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.

Decided
Feb 4, 2016
Review
267 days
Class
Class U
Product code
LQY
Recalls
None
Predicates
2

Its longest line of descent runs back 7 generations to K951425 (1995). 15 ancestors in all, the oldest K921979 (1993). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor2003: 1 other ancestor2005: 1 other ancestor2002: 1 other ancestor1997: 1 other ancestor2000: 1 other ancestor2018: 1 descendant clearedK951425 · Spectrum Curing Light Polymerization Unit · Dentsply Intl. · 1995K982318 · Spectrum 800 Curing Unit · Dentsply Intl. · 1998K031615 · Sled Curing Light System · Dentsply International · 2003K041372 · Smartlite PS Pen-Style Led Curing Light · Dentsply International · 2004K063529 · Pencure, Model VL-7 · J. Morita USA, Inc. · 2007K071190 · Root ZX II · J. Morita USA, Inc. · 2007K090925 · Multiple (Apex Locator), Model RCM-7 · J. Morita USA, Inc. · 20091990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 1 other ancestor4 generations back: 2 other ancestors5 generations back: 1 other ancestor6 generations back: 1 other ancestor 1 generation forward: 1 descendant K090925 · Multiple (Apex Locator), Model RCM-7 · J. Morita USA, Inc. · 2009K071190 · Root ZX II · J. Morita USA, Inc. · 2007K063529 · Pencure, Model VL-7 · J. Morita USA, Inc. · 2007K041372 · Smartlite PS Pen-Style Led Curing Light · Dentsply International · 2004K031615 · Sled Curing Light System · Dentsply International · 2003K982318 · Spectrum 800 Curing Unit · Dentsply Intl. · 1998K951425 · Spectrum Curing Light Polymerization Unit · Dentsply Intl. · 1995−50
  1. Root · 7 generations backK951425 Spectrum Curing Light Polymerization UnitDentsply Intl. · 1995
  2. 6 generations backK982318 Spectrum 800 Curing UnitDentsply Intl. · 1998
  3. 5 generations backK031615 Sled Curing Light SystemDentsply International · 2003
  4. 4 generations backK041372 Smartlite PS Pen-Style Led Curing LightDentsply International · 2004
  5. 3 generations backK063529 Pencure, Model VL-7J. Morita USA, Inc. · 2007
  6. 2 generations backK071190 Root ZX IIJ. Morita USA, Inc. · 2007
  7. 1 generation backK090925 Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009
  8. This deviceK151274 Dr's FinderGood Doctors Co., Ltd. · 2016
  9. Descendant · cites it directly · 0 of its ownK171867 Dr’s Finder NEOGood Doctors Co., Ltd. · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K171867Dr’s Finder NEOGood Doctors Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K951425Spectrum Curing Light Polymerization UnitDentsply Intl.1995—
−6K982318Spectrum 800 Curing UnitDentsply Intl.1998—
−5K031615Sled Curing Light SystemDentsply International2003—
−4K041372Smartlite PS Pen-Style Led Curing LightDentsply International2004—
−3K063529Pencure, Model VL-7J. Morita USA, Inc.2007—
−2K071190Root ZX IIJ. Morita USA, Inc.2007—
−1K090925Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc.2009—
0 (this device)K151274Dr's FinderGood Doctors Co., Ltd.2016—
+1K171867Dr’s Finder NEOGood Doctors Co., Ltd.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199510
199710
200010
200210
200310
200510
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K151274, 1995–2018Source: 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 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. #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? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K083901Navi Root
Summary page 4
…• Classification: Unclassified (Pre-Amendment) • Product Code: LQY 4. Predicate Device • Primary Predicate Device: NAVI ROOT by S-Denti Co., Ltd. (K083901) • Reference Predicate Devices: Multiple (Apex Locator), Model RCM-7 by J. MRITAMFG. CORP (K090925) 5. Description:…
S-Denti Co., Ltd.2009—
*K090925Multiple (Apex Locator), Model RCM-7
Summary page 4
…Predicate Device: NAVI ROOT by S-Denti Co., Ltd. (K083901) • Reference Predicate Devices: Multiple (Apex Locator), Model RCM-7 by J. MRITAMFG. CORP (K090925) 5. Description: The device allows the relative position of a dental file and the apex to be determined electrically. Usi…
J. Morita USA, Inc.2009—

Also cleared against K083901: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K171867Dr’s Finder NEOGood Doctors Co., Ltd.20180

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 21 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
  • None of the 15 ancestors has a recall.
  • Of its descendants, K171867 (Good Doctors Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K083901.

How does its category compare?

All LQY devices

LQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

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?

Dr’s Finder is intended for detecting the apex of root canal.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K151274: Dr's Finder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151274

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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