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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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