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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K251454
Device Name Clear Aligner (SCF-3348)
Applicant
Beame Medical Technology (Shenzhen) Limited
B03, B05, B06, 3rd Floor, Carrianna Friendship Square, 2002
Renminnan Rd., Luohu District
Shenzhen,  CN 518000
Applicant Contact Yajuan Ou
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90 Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Riley Chen
Regulation Number872.5470
Classification Product Code
NXC  
Date Received05/12/2025
Decision Date 01/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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