LQY

FDA Product Code LQY: Locator, Root Apex

Leading manufacturers include J. Morita USA, Inc., Parkell, Inc. and Sybron Dental Specialties, Inc..

46
Total
46
Cleared
165d
Avg days
1987
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 200d recently vs 162d historically

FDA 510(k) Cleared Locator, Root Apex Devices (Product Code LQY)

46 devices
1–24 of 46
Cleared Apr 08, 2026
Apex Locator (FindPex)
K252224
Changzhou Sifary Medical Technology Co., Ltd.
Dental · 266d
Cleared Mar 07, 2025
Apex Locator
K242383
Shenzhen Rogin Medical Co., Ltd.
Dental · 207d
Cleared Jan 17, 2025
Electronic Apex Locator (Alpha Apex I)
K242765
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Dental · 126d
Cleared Feb 13, 2024
Apex Locator
K231990
Cefla S.C.
Dental · 223d
Cleared Dec 22, 2023
Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
K232717
Changzhou Haili Medical Co., Ltd.
Dental · 108d
Cleared Jul 20, 2022
Root Apex Locator
K212178
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 373d
Cleared Oct 20, 2021
EQ-PEX
K210789
Meta Systems Co., Ltd.
Dental · 218d
Cleared Mar 30, 2021
BOMEDENT Apex locator, WISMY Apex locator
K203836
Changzhou Bomedent Medical Technology Co.,Ltd
Dental · 90d
Cleared Oct 03, 2019
Propex IQ Apex Locator
K191806
Dentsply Sirona
Dental · 90d
Cleared Dec 18, 2018
Apex Locator, DPEX III
K181087
Guilin Woodpecker Medical Instrument Co., Ltd.
Dental · 237d
Cleared Mar 30, 2018
Dr’s Finder NEO
K171867
Good Doctors Co., Ltd.
Dental · 281d
Cleared Jan 31, 2014
RAYPEX 6
K131907
Dentsply International, Inc.
Dental · 219d
Cleared Nov 23, 2009
MULTIPLE (APEX LOCATOR), MODEL RCM-7
K090925
J. Morita USA, Inc.
Dental · 235d
Cleared Dec 20, 2002
DENTA PORT
K022147
J. Morita USA, Inc.
Dental · 171d
Cleared Aug 30, 2000
FORAMATRON V, MODEL D680
K002195
Parkell, Inc.
Dental · 41d
Cleared Oct 08, 1996
APEX FINDER MODELS 7005
K962803
Sybron Dental Specialties, Inc.
Dental · 82d
Cleared Dec 01, 1995
ROOT CANAL LENGTH MEASURING DEVICE
K953867
J. Morita USA, Inc.
Dental · 106d
Cleared Apr 20, 1995
FORAMATRON IV
K950857
Parkell, Inc.
Dental · 52d
Cleared Jan 20, 1995
PULPDENT CANAL FINDER
K945811
Pulpdent Corp.
Dental · 53d
Cleared May 27, 1993
ROOT ZX
K921979
J. Morita USA, Inc.
Dental · 394d

About Product Code LQY - Regulatory Context

510(k) Submission Activity

46 total 510(k) submissions under product code LQY since 1987, with 46 receiving FDA clearance (average review time: 165 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LQY Product Code

Recent submissions under LQY have taken an average of 200 days to reach a decision - up from 162 days historically. Manufacturers should account for longer review timelines in current project planning.

LQY devices are reviewed by the Dental panel. Browse all Dental devices →