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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K250280
Device Name SD TL Implant System
Applicant
Arum Dentistry Co., Ltd.
23 Gukjegwahak 11-Ro, Yuseong-Gu
Daejeon,  KR 34002
Applicant Contact Choi Won-Yi
Correspondent
Arum Dentistry Co., Ltd.
23 Gukjegwahak 11-Ro, Yuseong-Gu
Daejeon,  KR 34002
Correspondent Contact Choi Won-Yi
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/31/2025
Decision Date 07/23/2025
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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