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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K232676
Device Name Dental Porcelain Powder
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 Number872.6660
Classification Product Code
EIH  
Date Received09/01/2023
Decision Date 01/23/2024
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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