Product Code: LQY FDA unclassified

Locator, Root Apex

Unknown

A root apex locator is a dental electronic device used during endodontic procedures to determine the position of the root apex and the length of the root canal, enabling more precise and safe cleaning and filling of the canal. This device is currently unclassified (Class U) by the FDA, meaning it has not yet been placed into a final regulatory classification category. The product code is LQY; no regulation number or medical specialty is on file for this entry. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LQY
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 46 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252224	Apex Locator (FindPex)	Apr 08, 2026	Substantially Equivalent	Changzhou Sifary Medical Technology Co., Ltd.
K242383	Apex Locator	Mar 07, 2025	Substantially Equivalent	Shenzhen Rogin Medical Co., Ltd.
K242765	Electronic Apex Locator (Alpha Apex I)	Jan 17, 2025	Substantially Equivalent	SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
K231990	Apex Locator	Feb 13, 2024	Substantially Equivalent	Cefla S.C.
K232717	Apex Locator (AL-Pex), Apex Locator (AL-Pex+)	Dec 22, 2023	Substantially Equivalent	Changzhou Haili Medical Co., Ltd.
K212178	Root Apex Locator	Jul 20, 2022	Substantially Equivalent	Foshan Coxo Medical Instrument Co., Ltd.
K210789	EQ-PEX	Oct 20, 2021	Substantially Equivalent	Meta Systems Co., Ltd.
K203836	BOMEDENT Apex locator, WISMY Apex locator	Mar 30, 2021	Substantially Equivalent	Changzhou Bomedent Medical Technology Co.,Ltd
K191806	Propex IQ Apex Locator	Oct 03, 2019	Substantially Equivalent	Dentsply Sirona
K181087	Apex Locator, DPEX III	Dec 18, 2018	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.
K171867	Drs Finder NEO	Mar 30, 2018	Substantially Equivalent	Good Doctors Co., Ltd.
K151274	Dr's Finder	Feb 04, 2016	Substantially Equivalent	Good Doctors Co., Ltd.
K131907	RAYPEX 6	Jan 31, 2014	Substantially Equivalent	Dentsply International, Inc.
K121206	DETECT	Jan 10, 2013	Substantially Equivalent	Forum Engineering Technologies, Ltd.
K112508	I-ROOT 100	Jun 19, 2012	Substantially Equivalent	S-Denti Co., Ltd.
K112153	IROOT 100 MINI	Apr 26, 2012	Substantially Equivalent	S-Denti Co., Ltd.
K111474	BINGO PRO	Nov 02, 2011	Substantially Equivalent	Forum Engineering Technologies (96) , Ltd.
K103123	APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES)	Mar 10, 2011	Substantially Equivalent	Micro-Mega Societe Anonyme
K100450	I-ROOT	Nov 18, 2010	Substantially Equivalent	S-Denti Co., Ltd.
K101177	APEXNRG RIDER	Oct 08, 2010	Substantially Equivalent	Medicnrg , Ltd.
K101054	ROMIAPEX MODEL A-15	Sep 03, 2010	Substantially Equivalent	Romidan, Ltd.
K090925	MULTIPLE (APEX LOCATOR), MODEL RCM-7	Nov 23, 2009	Substantially Equivalent	J. Morita USA, Inc.
K083901	NAVI ROOT	Apr 15, 2009	Substantially Equivalent	S-Denti Co., Ltd.
K073185	APX21	Mar 06, 2008	Substantially Equivalent	Techdent Technologies, Ltd.
K080113	APEX DAL ELECTRONIC APEX LOCATOR	Feb 15, 2008	Substantially Equivalent	Medicnrg , Ltd.
K071133	APEXNRG-BLUE ELECTRONIC APEX LOCATOR	Sep 21, 2007	Substantially Equivalent	Medicnrg , Ltd.
K063843	APEXNRG XFR	Jan 03, 2007	Substantially Equivalent	Medicnrg , Ltd.
K053235	NSK PRECISION APEX LOCATOR (PAL)	Jan 24, 2006	Substantially Equivalent	Medicsense USA
K032743	APEX NRG	Mar 15, 2004	Substantially Equivalent	Medicnrg , Ltd.
K030895	ASEPTICO ENDOPEX V, MODEL AEU-40	Dec 03, 2003	Substantially Equivalent	Aseptico, Inc.
K022147	DENTA PORT	Dec 20, 2002	Substantially Equivalent	J. Morita USA, Inc.
K022020	JUSTWO MODEL TME-601 ROOT APEX LOCATOR	Jul 02, 2002	Substantially Equivalent	Toei Electric Co., Ltd.
K002195	FORAMATRON V, MODEL D680	Aug 30, 2000	Substantially Equivalent	Parkell, Inc.
K992233	APEX LOCATOR BINGO-1020	Nov 30, 1999	Substantially Equivalent	Dent Corp. Research & Development
K972407	ROOT APEX LOCATOR	Sep 11, 1997	Substantially Equivalent	Toei Electric Co., Ltd.
K962803	APEX FINDER MODELS 7005	Oct 08, 1996	Substantially Equivalent	Sybron Dental Specialties, Inc.
K962853	NEOSONO	Sep 12, 1996	Substantially Equivalent	L.S. Scientific
K955088	NEOSONO 2000	Jul 10, 1996	Substantially Equivalent	American Medical & Dental Corp.
K953867	ROOT CANAL LENGTH MEASURING DEVICE	Dec 01, 1995	Substantially Equivalent	J. Morita USA, Inc.
K950857	FORAMATRON IV	Apr 20, 1995	Substantially Equivalent	Parkell, Inc.
K945811	PULPDENT CANAL FINDER	Jan 20, 1995	Substantially Equivalent	Pulpdent Corp.
K921979	ROOT ZX	May 27, 1993	Substantially Equivalent	J. Morita USA, Inc.
K904742	OSADA ENDEX	Dec 17, 1990	Substantially Equivalent	Osada Electric Co., Ltd.
K890735	COATED APEX PROBE	Apr 19, 1989	Substantially Equivalent	Analytic Technology
K863393	ENDOCATER	Jun 11, 1987	Substantially Equivalent	The Hygenic Corp.
K864500	ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001	Mar 19, 1987	Substantially Equivalent	Analytic Technology