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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 K242407
Device Name Dental Glass Ceramics Blocks (HT, LT, MT)
Applicant
Hunan Vsmile Biotechnology Co., Ltd.
Rm..1202-1203, Huanchuang Enterprise Sq.
Bldg. A4 #2450 Yuelu W. Ave.
Hi-Tech Development District Changsha,  CN 410000
Applicant Contact Xiaomi Tang
Correspondent
Hunan Vsmile Biotechnology Co., Ltd.
Rm..1202-1203, Huanchuang Enterprise Sq.
Bldg. A4 #2450 Yuelu W. Ave.
Hi-Tech Development District Changsha,  CN 410000
Correspondent Contact Xiaomi Tang
Regulation Number872.6660
Classification Product Code
EIH  
Date Received08/14/2024
Decision Date 11/13/2024
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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