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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K210333
Device Name DiaPaste
Applicant
Diadent Group International
16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu
Cheongju-si,  KR 28161
Applicant Contact Kab Sun Lee
Correspondent
Diadent Group International
16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu
Cheongju-si,  KR 28161
Correspondent Contact Kab Sun Lee
Regulation Number872.3820
Classification Product Code
KIF  
Date Received02/05/2021
Decision Date 03/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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