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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
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