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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K251818
Device Name BONTREE PLUS
Applicant
Hudens Bio Co., Ltd.
#318, Cheomdanyeonsin-Ro, Buk-Gu
Gwangju,  KR 61088
Applicant Contact Hun Kim
Correspondent
K-Bio Solutions
Suite 701, 125 Seochojungang-Ro, Seocho-Gu
Seoul,  KR 06644
Correspondent Contact Kyungyoon Kang
Regulation Number872.3930
Classification Product Code
LYC  
Date Received06/13/2025
Decision Date 03/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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