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510(k) Data Aggregation
K Number
K232717Device Name
Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
Manufacturer
Changzhou Haili Medical Co., Ltd.
Date Cleared
2023-12-22
(108 days)
Product Code
LQY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Changzhou Haili Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
support the dentist in the determination of the working the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.
Device Description
Apex locators are equipment used for working length measurement during root canal treatment. The devices are powered by a built-in lithium battery, can be charged by a USB adaptor. The devices employ a LCD screen to display the status of file in the root canal and the relative distance between file tip and reference point.
The devices are reusable medical devices initially supplied as non-sterile to the user and requiring the user to clean and disinfect the surface of device. And their accessory, Dental root canal file clip, Dental lip hook and probe are reusable, initially supplied as non-sterile to the user, and requiring the user to sterile for initial use, as well as to reprocess after each use.
The devices include a main unit, a measurement wire A, a measurement wire B, a dental root canal file clip, a dental lip hook, a probe and an adaptor.
Main unit: measure and display working length.
Measurement wire A: connect file clip and lip hook with main unit.
Measurement wire B: connect lip hook and main unit with EM-Motor root canal preparation device.(The EM-Motor root canal preparation device is not included with the subject device and is sold separately.)
File clip: Connect to file.
Lip hook: hook patient's lip.
Touch Probe: promote to measure molar.
Power Adapter: use for charging.
Tester: use for checking whether the device is normal.
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