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FDA 510(k)

Apex Locator

K-Number: K242383 · 2025-03-07

ApplicantShenzhen Rogin Medical Co., Ltd.
Decision Date2025-03-07
Product CodeLQY
DecisionSubstantially Equivalent

Device Summary

Apex Locator is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Rogin Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-03-07 under 510(k) number K242383. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Apex Locator?

Apex Locator is a medical device that received FDA 510(k) clearance on 2025-03-07. The listed applicant is Shenzhen Rogin Medical Co., Ltd.. The 510(k) number is K242383.

When did Apex Locator receive FDA 510(k) clearance?

Apex Locator received FDA 510(k) clearance on 2025-03-07, under 510(k) number K242383.

Who is the listed applicant for Apex Locator?

The FDA 510(k) record lists Shenzhen Rogin Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Apex Locator?

The FDA product code for Apex Locator is LQY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07526818Comparison of Manual and Mechanical Glide Path Techniques for Measuring Root Canal Length Using Standalone Apex Locator and an Endomotor With built-in Apex Locator.ACTIVE_NOT_RECRUITINGNCT07527897Effect of Integrated Apex Locator Motor Modes on Postoperative Pain in Endodontic RetreatmentCOMPLETEDNCT07642349Effect of Different Apical Termination Point Guided by Electronic Apex Locator on Post Endodontic Pain , A Randomized Control Trial.COMPLETEDNCT07689838In Vivo-Ex Vivo Evaluation of the Root ZX3 for Working-Length DeterminationCOMPLETED

Other records listing Shenzhen Rogin Medical Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)

Related Devices (Code: LQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252224Apex Locator (FindPex)Changzhou Sifary Medical Technology Co., Ltd.K242765Electronic Apex Locator (Alpha Apex I)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K231990Apex LocatorCefla S.C.K232717Apex Locator (AL-Pex), Apex Locator (AL-Pex+)Changzhou Haili Medical Co., Ltd.K212178Root Apex LocatorFoshan Coxo Medical Instrument Co., Ltd.K210789EQ-PEXMeta Systems Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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