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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K260795
Device Name Hand-held Dental X-ray System (HyperLight-M)
Applicant
Changzhou Sifary Medical Technology Co., Ltd.
# 26 Yandanghe Rd., Xinbei District
Changzhou,  CN 213000
Applicant Contact Qingfei Pan
Correspondent
Changzhou Sifary Medical Technology Co., Ltd.
# 26 Yandanghe Rd., Xinbei District
Changzhou,  CN 213000
Correspondent Contact Qingfei Pan
Regulation Number872.1800
Classification Product Code
EHD  
Date Received03/11/2026
Decision Date 09/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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