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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K252286
Device Name BIORES Dental Implant System
Applicant
Chengdu Besmile Medical Technology Co., Ltd.
#9,Sec.2, Shengwucheng N. Rd.
Chengdu Tianfu International Bio-Town, Shuangliu District
Chengdu,  CN 610200
Applicant Contact Moushan Liu
Correspondent
Chengdu Besmile Medical Technology Co., Ltd.
#9,Sec.2, Shengwucheng N. Rd.
Chengdu Tianfu International Bio-Town, Shuangliu District
Chengdu,  CN 610200
Correspondent Contact Moushan Liu
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received07/23/2025
Decision Date 02/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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