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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 K252224
Device Name Apex Locator (FindPex)
Applicant
Changzhou Sifary Medical Technology Co., Ltd.
# 26 Yandanghe Rd., Xinbei District
Changzhou,  CN 213000
Applicant Contact Jie Zhu
Correspondent
Changzhou Sifary Medical Technology Co., Ltd.
# 26 Yandanghe Rd., Xinbei District
Changzhou,  CN 213000
Correspondent Contact Jie Zhu
Classification Product Code
LQY  
Date Received07/16/2025
Decision Date 04/08/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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