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EQ-PEX is an Electronic Apex Locator designed for use in measuring the working length of root canals.

EQ-PEX is Electronic Apex Locator and accessories to be used to treat of patients. It consists of the main body and lip hook, probe cord and 2 kinds of file holder. The device is used to track the position of the file in the root canal based on the impedance of two different frequencies. The device is intended for measuring the length of the root canal treatments. The components of the device include the main body, probe cord, lip book, file holder, AC adapter, and power cord.

The screen displays measurement information of the root canal length at the current location of the file and displays a number and graph. Stainless steel hand files are intended to be used with the subject device. Lip hook is intended to be placed on the opposite lip of the tooth to be worked on. The file is slowly inserted into the root canal. When the file approaches the apex reference value and alarm will beep and the text apex will appear on the measurement screen.

The provided text describes the 510(k) summary for the EQ-PEX Electronic Apex Locator. Based on the document, here's a description of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The primary performance criterion for the EQ-PEX, as stated and compared to the predicate device, is Accuracy of Apex.

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