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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 K234112
Device Name Customized Abutment
Applicant
Arum Dentistry Co., Ltd.
23 Gukjegwahak 11-Ro, Yuseong-Gu
Daejeon,  KR 34002
Applicant Contact Boyeon Lim
Correspondent
Arum Dentistry Co., Ltd.
23 Gukjegwahak 11-Ro, Yuseong-Gu
Daejeon,  KR 34002
Correspondent Contact Boyeon Lim
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
DZE  
Date Received12/27/2023
Decision Date 05/09/2024
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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