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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Locator, Root Apex
510(k) Number K232717
Device Name Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
Applicant
Changzhou Haili Medical Co., Ltd.
Hutang Science Technology Industrial Park,
Wujin District
Changzhou,  CN 213000
Applicant Contact Wang Xiaofang
Correspondent
Changzhou Haili Medical Co., Ltd.
Hutang Science Technology Industrial Park,
Wujin District
Changzhou,  CN 213000
Correspondent Contact Wang Xiaofang
Classification Product Code
LQY  
Date Received09/05/2023
Decision Date 12/22/2023
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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