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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K261071
Device Name DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)
Applicant
DiaDent Group International
16, Osongsaengmyeong 4-Ro, Osong-Eup, Heungdeok-Gu
Cheongju-Si,  KR 28186
Applicant Contact Seung-Geun Lee
Correspondent
DiaDent Group International
16, Osongsaengmyeong 4-Ro, Osong-Eup, Heungdeok-Gu
Cheongju-Si,  KR 28186
Correspondent Contact Seung-Geun Lee
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/01/2026
Decision Date 05/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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