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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 K182625
Device Name Diapex Plus
Applicant
DiaDent Group International
16, Osongsaengmyeong 4-Ro, Osong-Eup, Heungdeok-Gu
Cheongju-Si,  KR 28161
Applicant Contact Myung sub Kim
Correspondent
DiaDent Group International
16, Osongsaengmyeong 4-Ro, Osong-Eup, Heungdeok-Gu
Cheongju-Si,  KR 28161
Correspondent Contact Myung sub Kim
Regulation Number872.3820
Classification Product Code
KIF  
Date Received09/24/2018
Decision Date 06/03/2019
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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