510(k) · Cleared

Cleared

Apex Pointer+; Measruing Cable, Hook, Lip Clip, Touch Probe (Accessories)

K103123510(k) TraditionalCleared Mar 10, 2011140-day reviewClass U

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

Micro-Mega Societe Anonyme · LQY Locator, Root Apex

Cleared on Mar 10, 2011 as substantially equivalent to K073185 (Techdent Technologies, Ltd., 2008) after a 140-day review. Its family tree reaches back 2 generations to 1993.

Decided: Mar 10, 2011
Review: 140 days
Class: Class U
Product code: LQY
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K921979 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK921979 Root ZXJ. Morita USA, Inc. · 1993
1 generation backK073185 APX21Techdent Technologies, Ltd. · 2008
This deviceK103123 Apex Pointer+; Measruing Cable, Hook, Lip Clip, Touch Probe…Micro-Mega Societe Anonyme · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K921979	Root ZX	J. Morita USA, Inc.	1993	—
−1	K073185	APX21	Techdent Technologies, Ltd.	2008	—
0 (this device)	K103123	Apex Pointer+; Measruing Cable, Hook, Lip Clip, Touch Probe (Accessories)	Micro-Mega Societe Anonyme	2011	—

FIG. 1 — Lineage of K103123, 1993–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K073185	APX21 Summary page 1 …root apex Review Panel: Dental Product Code: LQY Device Class: Unclassified (Pre-Amendment) Devices to which substantial equivalence is claimed: K073185 APX21 TECHNOLOGIES, ____ _ ___…	Techdent Technologies, Ltd.	2008	—

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 18 years and passes through 3 companies; a new generation was cleared every 14.8 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All LQY devices

LQY 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

2007high 3 (2010) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LQY

164in 2010

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	2	—	0
2008	2	—	1
2009	2	—	15
2010	3	164	22
2011	2	—	140
2012	2	—	59
2013	1	—	2
2014	1	—	0
2015	0	—	59
2016	1	—	128
2017	0	—	133
2018	2	—	154
2019	1	—	163
2020	0	—	139
2021	2	—	107
2022	1	—	63
2023	1	—	56
2024	1	—	81
2025	2	—	51
2026	1	—	—

What is it indicated for?

The APEX POINTER+ is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103123 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103123: Apex Pointer+; Measruing Cable, Hook, Lip Clip, Touch Probe (Accessories).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103123

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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