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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
Predetermined Change
Control Plan Authorized		 No
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