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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 K222131
Device Name NB 1 SA Implant System
Applicant
Arum Dentistry Co., Ltd.
23 Gukjegwahak 11-Ro, Yuseong-Gu
Daejeon,  KR 34002
Applicant Contact Bo-Yeon Lim
Correspondent
Arum Dentistry Co., Ltd.
23 Gukjegwahak 11-Ro, Yuseong-Gu
Daejeon,  KR 34002
Correspondent Contact Bo-Yeon Lim
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received07/18/2022
Decision Date 09/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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