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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 K240603
Device Name Ti-Base & Master Fix
Applicant
Arum Dentistry Co., Ltd.
23 Gukjegwahak 11-Ro, Yuseong-Gu
Daejeon,  KR 34002
Applicant Contact Won-Yi Choi
Correspondent
Arum Dentistry Co., Ltd.
23 Gukjegwahak 11-Ro, Yuseong-Gu
Daejeon,  KR 34002
Correspondent Contact Won-Yi Choi
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/04/2024
Decision Date 06/05/2024
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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