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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 K192273
Device Name DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit
Applicant
Diadent Group International
16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu
Cheongu-si,  KR 28161
Applicant Contact Kab Sun Lee
Correspondent
Diadent Group International
16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu
Cheongu-si,  KR 28161
Correspondent Contact Kab Sun Lee
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
EBF  
Date Received08/22/2019
Decision Date 02/07/2020
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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