FDA.reportPublic FDA data

510(k) K254210

Device
REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)
Applicant
Hyundai Bioland Co., Ltd.
510(k) number
K254210
Product code
NPM
Decision
Substantially Equivalent (SESE)
Decision date
2026-09-25
Date received
2025-12-29
Regulation
872.3930
Classification name
Bone Grafting Material, Animal Source
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Seo Yeji
Address
162, Gwahaksaneop 3-Ro, Ochang-Eup, Cheongwon-Gu Cheongju-Si KR 28125 28125

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NPM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253723BOSSMedpark Co., Ltd.2026-06-16
K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AG2025-07-11
K251613SwissGraft XGeistlich Pharma AG2025-06-26
K242510Geistlich Bio-Flow®Geistlich Pharma AG2025-03-07
K240133Xenograft Bovine Bone ParticulateCollagen Solutions, LLC2024-08-16
K230305THE Graft CollagenPurgo Biologics, Inc.2024-07-24
K240661Geistlich Bio-Oss®Geistlich Pharma AG2024-07-12
K231672S1Medpark Co., Ltd.2023-10-13
K221808InterOss CollagenSigmagraft, Inc.2023-03-18
K211551Wishbone HAWishbone SA2021-08-20
K202183Porcine Mineral Collagen CompositeCollagen Matrix, Inc.2021-04-02
K201859Porcine Mineral Collagen Composite MoldableCollagen Matrix, Inc.2020-09-11
K193212DSM Biomedical Dental Bone Graft PlusDsm Biomedical2020-09-10
K191737The Graft Bone SubstitutePurgo Biologics, Inc.2020-02-14
K173594Straumann ceraboneInstitut Straumann AG2018-10-19