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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K232559
Device Name C&B NFH Hybrid
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 Number872.3690
Classification Product Code
EBF  
Subsequent Product Code
EBG  
Date Received08/23/2023
Decision Date 09/11/2024
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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