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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 K161851
Device Name Glass Ionomer Cement (Luting)
Applicant
Shandong Huge Dental Material Corporation
# 68 Shanhai Rd., Donggang District
Rizhao City,  CN 276800
Applicant Contact STEVEN SONG
Correspondent
Shandong Huge Dental Material Corporation
# 68 Shanhai Rd., Donggang District
Rizhao City,  CN 276800
Correspondent Contact STEVEN SONG
Regulation Number872.3275
Classification Product Code
EMA  
Date Received07/06/2016
Decision Date 10/31/2016
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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