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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K213401
Device Name DIAPLUS Universal
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 Number872.3200
Classification Product Code
KLE  
Date Received10/18/2021
Decision Date 01/31/2022
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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