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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K254286
Device Name Guided Bone Regeneration System
Applicant
DentalMaster(Xiamen)Medical Technology Co., Ltd.
#19-2, Dingshan Middle Rd., Haicang District
Xiamen,  CN 361027
Applicant Contact Junfeng Li
Correspondent
DentalMaster(Xiamen)Medical Technology Co., Ltd.
#19-2, Dingshan Middle Rd., Haicang District
Xiamen,  CN 361027
Correspondent Contact Junfeng Li
Regulation Number872.4880
Classification Product Code
DZL  
Date Received12/31/2025
Decision Date 08/24/2026
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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