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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K262207
Device Name Cemented Plus Abutment
Applicant
Unidental Co., Ltd.
#D-613, Gm Technopark
60 Haan-Ro
Gwangmyeong-Si,  KR 14322
Applicant Contact Sungjoon Yang
Correspondent
Unidental Co., Ltd.
#D-613, Gm Technopark
60 Haan-Ro
Gwangmyeong-Si,  KR 14322
Correspondent Contact Sungjoon Yang
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/30/2026
Decision Date 09/23/2026
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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