Apex Locator

FDA 510(k) K242383 · Shenzhen Rogin Medical Co., Ltd.

Substantially Equivalent

510(k) numberK242383

Submission

Device name
Apex Locator
Applicant
Shenzhen Rogin Medical Co., Ltd.
Shenzhen, CN
Received
August 12, 2024
Decision date
March 7, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LQY – Locator, Root Apex
Device class
Unclassified

Other 510(k)s with product code LQY

510(k)DeviceApplicantDecision
K252224Apex Locator (FindPex)LQY · Traditional Changzhou Sifary Medical Technology Co., Ltd.04/08/2026SE
K242765Electronic Apex Locator (Alpha Apex I)LQY · Traditional Shenzhen Superline Technology Co., Ltd.01/17/2025SE
K231990Apex LocatorLQY · Traditional Cefla S.C.02/13/2024SE
K232717Apex Locator (AL-Pex), Apex Locator (AL-Pex+)LQY · Traditional Changzhou Haili Medical Co., Ltd.12/22/2023SE
K212178Root Apex LocatorLQY · Traditional Foshan Coxo Medical Instrument Co., Ltd.07/20/2022SE
K210789Eq-PexLQY · Traditional Meta Systems Co., Ltd.10/20/2021SE
K203836BOMEDENT Apex locator, WISMY Apex locatorLQY · Traditional Changzhou Bomedent Medical Technology Co.,Ltd03/30/2021SE
K191806Propex IQ Apex LocatorLQY · Traditional Dentsply Sirona10/03/2019SE
K181087Apex Locator, DPEX IIILQY · Traditional Guilin Woodpecker Medical Instrument Co., Ltd.12/18/2018SE
K171867Dr’s Finder NEOLQY · Traditional Good Doctors Co., Ltd.03/30/2018SE

More from Good Doctors Co., Ltd.

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Questions and answers

When was Apex Locator cleared by the FDA?

Apex Locator (K242383) received a 510(k) decision of Substantially Equivalent on March 7, 2025, 207 days after the submission was received.

What is the product code of K242383?

The FDA product code is LQY – Locator, Root Apex, a Unclassified device.