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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K254112
Device Name Dia-X Sil Bite
Applicant
DiaDent Group International
16, Osongsaengmyeong 4-Ro, Osong-Eup, Heungdeok-Gu
Cheongju-Si,  KR 28186
Applicant Contact Jin An
Correspondent
DiaDent Group International
16, Osongsaengmyeong 4-Ro, Osong-Eup, Heungdeok-Gu
Cheongju-Si,  KR 28186
Correspondent Contact Jin An
Regulation Number872.3660
Classification Product Code
ELW  
Date Received12/19/2025
Decision Date 03/19/2026
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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