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510(k) Data Aggregation
K Number
K242765Device Name
Electronic Apex Locator (Alpha Apex I)
Manufacturer
Shenzhen Superline Technology Co., Ltd.
Date Cleared
2025-01-17
(126 days)
Product Code
LQY, LOY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Shenzhen Superline Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electronic Apex Locator is used to support the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.
Device Description
The Electronic Apex Locator is a microprocessor-controlled device used for root canal length determination. The Electronic Apex Locator assesses the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. By detecting the change of the impedance value of the tooth apex to the AC current response of two different frequencies, two signals are output that are proportional to the change of the AC current response of two different frequencies corresponding to the tooth apex, and the two response signals are compared, and the digital quantity of their ratio is output. The digital quantity represents the position of the electrode at the tooth apex.
Advanced user interface implemented in Electronic Apex Locator is based on high resolution TFT (Thin Film Transistor) color graphic display. It provides presentation of endodontic file movement inside the canal. In addition, the interface displays the mute or volume level and power status.
The product is functionally operated by three buttons: 1) On/off button of the main unit: Short press once to hear a beep is to start up the machine, short press once again to shut down, and long press no response. 2) Volume button: Under the startup state, press once to increase one volume. After reaching the maximum volume, press once to enter the mute mode. Press four times as a cycle, and there will be no responds when long press. 3) DEMO button: Under the startup state, long press to enter the DEMO process, and the screen will demonstrate the process of measuring the length.
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