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FDA 510(k)

Electronic Apex Locator (Alpha Apex I)

K-Number: K242765 · 2025-01-17

ApplicantSHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Decision Date2025-01-17
Product CodeLQY
DecisionSubstantially Equivalent

Device Summary

Electronic Apex Locator (Alpha Apex I) is a medical device manufactured by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.. It received FDA 510(k) clearance on 2025-01-17 under approval number K242765. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electronic Apex Locator (Alpha Apex I)?

Electronic Apex Locator (Alpha Apex I) is a medical device that received FDA 510(k) clearance on 2025-01-17. It is manufactured by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.. The 510(k) number is K242765.

When was Electronic Apex Locator (Alpha Apex I) approved by the FDA?

Electronic Apex Locator (Alpha Apex I) received FDA 510(k) clearance on 2025-01-17, under approval number K242765.

What company makes Electronic Apex Locator (Alpha Apex I)?

Electronic Apex Locator (Alpha Apex I) is manufactured by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD..

What is the FDA product code for Electronic Apex Locator (Alpha Apex I)?

The FDA product code for Electronic Apex Locator (Alpha Apex I) is LQY.

Related Clinical Trials

NCT07526818 Comparison 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_RECRUITING NCT07527897 Effect of Integrated Apex Locator Motor Modes on Postoperative Pain in Endodontic Retreatment COMPLETED

Other Devices by SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.

K252223Alpha Endo Handpiece (Alpha Endo)

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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