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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 a medical device manufactured by Shenzhen Rogin Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-03-07 under approval 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. It is manufactured by Shenzhen Rogin Medical Co., Ltd.. The 510(k) number is K242383.

When was Apex Locator approved by the FDA?

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

What company makes Apex Locator?

Apex Locator is manufactured by Shenzhen Rogin Medical Co., Ltd..

What is the FDA product code for Apex Locator?

The FDA product code for Apex Locator is LQY.

Other Devices by Shenzhen Rogin Medical Co., Ltd.

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

Related Devices (Code: LQY)

K151274Dr's FinderGood Doctors Co., Ltd. K181087Apex Locator, DPEX IIIGuilin Woodpecker Medical Instrument Co., Ltd. K171867Dr’s Finder NEOGood Doctors Co., Ltd. K191806Propex IQ Apex LocatorDentsply Sirona K210789EQ-PEXMeta Systems Co., Ltd. K203836BOMEDENT Apex locator, WISMY Apex locatorChangzhou Bomedent Medical Technology 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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