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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name crown and bridge, temporary, resin
510(k) Number K192022
Device Name DiaTemp Flow
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 Number872.3770
Classification Product Code
EBG  
Date Received07/29/2019
Decision Date 02/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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