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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, Animal Source
510(k) Number K254210
Device Name REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)
Applicant
Hyundai Bioland Co., Ltd.
162, Gwahaksaneop 3-Ro, Ochang-Eup, Cheongwon-Gu
Cheongju-Si,  KR 28125
Applicant Contact Seo Yeji
Correspondent
Hyundai Bioland Co., Ltd.
162, Gwahaksaneop 3-Ro, Ochang-Eup, Cheongwon-Gu
Cheongju-Si,  KR 28125
Correspondent Contact Seo Yeji
Regulation Number872.3930
Classification Product Code
NPM  
Date Received12/29/2025
Decision Date 09/25/2026
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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