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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K241204
Device Name TopCEM-Veneer Light Cure Veneer Cement
Applicant
Rizhao Huge Biomaterials Company, Ltd.
#2 N. Zhaoyang Rd., District Of Donggang
Rizhao,  CN 276800
Applicant Contact Maggie Zheng
Correspondent
Rizhao Huge Biomaterials Company, Ltd.
#2 N. Zhaoyang Rd., District Of Donggang
Rizhao,  CN 276800
Correspondent Contact Maggie Zheng
Regulation Number872.3275
Classification Product Code
EMA  
Subsequent Product Code
EBF  
Date Received04/30/2024
Decision Date 06/28/2024
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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