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Medical DevicesKOSDAQ 13861030 approvals1 trials

NIBEC CO., LTD.

Founded in 2004 and listed on KOSDAQ in 2011, NIBEC develops dental tissue regeneration biomaterials and peptide-based biomaterials.

As of 2026-10-10, NIBEC CO., LTD. has 22 Korean MFDS device approvals, 7 Korean MFDS drug approvals, 1 US FDA clearance/approval, 35 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Products & technology

  • Dental bone graft OCS-BFilling alveolar bone defects and securing bone volume for implant procedures
  • Dental bone graft OCS-HFilling alveolar bone defects and securing bone volume for implant procedures
  • Tissue regeneration membrane XenoGideUsed with bone graft material to block connective tissue invasion
  • Tissue regeneration membrane GuidOssUsed with bone graft material to block connective tissue invasion
  • Collagen filler RegenomerExtraction socket filler
  • Sheet-form collagen graft RegenoMatrixGuided periodontal tissue regeneration for gingival/periodontal soft tissue reconstruction
  • Bone graft-collagen composite OCS-B CollagenComposite bone graft combining high-purity biocollagen with OCS-B bone graft
  • Bone graft-collagen composite Equimatrix-CollagenComposite bone graft combining high-purity biocollagen with OCS-H bone graft
  • Peptide-fused bone graft OssGen-X15Fusion of bone-regenerating peptide with OCS-B bone graft for bone regeneration in elderly/chronic disease patients and large bone defects
  • PeptiCol EZgraftPeriodontal tissue regeneration device composed of osteogenic peptide, photoreactive collagen gel, and collagen sponge
  • PeptiCol EZgraft OssBiomaterial combining peptide-fused bone graft OssGen-X15 with collagen regeneration material
  • Periodontitis in-vitro diagnostic deviceIn-vitro diagnostic device quantifying salivary cytokine MMP-8 via electrochemical impedance spectroscopy
  • Hypersensitivity device SensBlokDelivers nerve-desensitizing agents and blocks stimulus transmission via polymer coating and calcium formation promotion
  • Dental conditioner ClinplantRemoves plaque and tartar to prevent periodontal inflammation and peri-implantitis
  • Oral health products including dental antibiotic ointment and hypersensitivity treatmentSuppression of periodontal disease-causing bacteria, hypersensitivity treatment, tooth whitening

Regulatory approvals

data.go.kr · openFDA

7 Korean MFDS drug approvals · 2015 / 22 Korean MFDS device approvals · 2005–2026 / 1 US FDA 510(k) · 2015

  • MFDSDressing, collagen, wound2026-08-04
    Product approval · Class 3제허 26-596 호
  • MFDSBone graft material, animal source or other living things’ source2026-04-30
    Product approval · Class 4제허 26-325 호
  • MFDSProtein analyzer, electronic, plasmonic2025-02-27
    Product approval · Class 1체외 제신 25-223 호
  • MFDSBone graft material, animal source or other living things’ source2024-12-24
    Product approval · Class 4제허 24-900 호
  • MFDSDental polymerization activator- visible light2022-11-04
    Product approval · Class 1대전 제신 22-1537 호
  • MFDSBarrier, intra oral, resorbable2020-04-09
    Product approval · Class 4제허 20-277 호
  • MFDSBarrier, intra oral, resorbable2019-10-18
    Product approval · Class 4제허 19-659 호
  • MFDSagent, dentine, conditioner2018-10-12
    Product approval · Class 1제신 18-1327 호
  • FDARegenomer® Syringe, Regenomer® Plug, Regenomer® Block2015-12-10
    510(k) · AbbreviatedDentalK150079
  • MFDS drug블랑티스에프프로겔15%Revoked2015-07-27
    Drug · OTC · Notification201505111
  • MFDS drug닥터화이티스35%(수출용)2015-06-18
    Drug · Prescription · Approval201503950
  • MFDS drug블랑티스프로겔10%(카바마이드퍼옥사이드)Revoked2015-06-08
    Drug · OTC · Notification201503646
Show 18 more
  • MFDS drug닥터화이티스20%(수출용)2015-06-05
    Drug · Prescription · Approval201503609
  • MFDS drug미노큐어치과용연고(미노사이클린염산염)2015-05-29
    Drug · Prescription · Notification201503299
  • MFDS drug닥터화이티스15%(수출용)2015-05-11
    Drug · OTC · Notification201502814
  • MFDS drug닥터화이티스10%(카바마이드퍼옥사이드)(수출용)2015-04-08
    Drug · OTC · Notification201501888
  • MFDSagent, dentine, conditioner2015-03-27
    Product approval · Class 1대전 제신 15-32 호
  • MFDSagent, dentine, conditioner2015-01-29
    Product approval · Class 1대전 제신 15-8 호
  • MFDSDental syringeRevoked2014-12-22
    Product approval · Class 1대전 수신 14-93 호
  • MFDSBone graft material, composit2014-07-25
    Product approval · Class 4제허 14-1387 호
  • MFDSBone graft material, composit2013-12-13
    Product approval · Class 4제허 13-2124 호
  • MFDSBone graft material, animal source or other living things’ source2011-10-12
    Product approval · Class 4제허 11-1125 호
  • MFDSBone graft material, syntheticRevoked2011-09-21
    Product approval · Class 4수허 11-1104 호
  • MFDSBarrier, intra oral, resorbable2011-08-01
    Product approval · Class 4제허 11-854 호
  • MFDSBarrier, intra oral, resorbable2011-04-12
    Product approval · Class 4제허 11-403 호
  • MFDSagent, dentine, conditionerRevoked2009-12-17
    Product approval · Class 1서울 제신 09-250 호
  • MFDSmaterial, dentine, desensitizer2008-08-01
    Product approval · Class 2제인 08-505 호
  • MFDSBone graft material, animal source or other living things’ source2007-06-21
    Product approval · Class 4제허 07-333 호
  • MFDS치주조직재생유도재Revoked2006-03-09
    Product approval · Class 4제허 06-182 호
  • MFDSBone graft material, animal source or other living things’ source2005-09-15
    Product approval · Class 4제허 05-744 호

Clinical trials

data.go.kr

1 MFDS clinical trial authorisations · 2020 (Phase 1 1)

  • Phase 1오세오타이드 아세트산염 주2020-02-03

    3 trial sites

Global clinical trials

ClinicalTrials.gov · sponsor-matched

R&D and key agreements

Source: DART corporate disclosure

Pepticol 이지그라프트 소재기반 조직재생 유도 의료기기 · 치주조직 재생, 염증 제어 · R&D project via a multi-ministry medical device R&D program combining specific amino acid-containing collagen with anti-inflammatory functional peptides to control the inflammatory environment

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched
Show 25 more publications

Patents

KIPRIS · applicant-matched
Show 115 more patents

AI reads

MAA server logs · IP-verified
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Times AI engines pulled NIBEC CO., LTD.'s records

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Companies approved for the same productsMedical Devices

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

SHINHUNG CO.,LTD5 shared

Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.

OSCOTECInc.3 shared

KOSDAQ-listed drug developer whose out-licensed targeted lung cancer therapy has received approval from Korea's MFDS and the US FDA.

METABIOMED.CO.,LTD3 shared

KOSDAQ-listed medical device company manufacturing synthetic bioresorbable suture yarn and dental root canal filling materials.

DENTIS CO.,LTD3 shared

Founded in 2016 and listed on KOSDAQ in 2017, DENTIS manufactures dental implants, medical LED lighting, and dental 3D printers.

DIO Corporation2 shared

DIO Corporation, established in 1988 and listed on KOSDAQ in 2000, manufactures and sells dental implants.

Samyang Biopharm Corporation2 shared

Founded and KOSPI-listed in 2025, Samyang Biopharm develops medical devices, pharmaceuticals, and new drug candidates.

OSTEONIC Co., Ltd.2 shared

Established in 2012 and listed on KOSDAQ in 2018, Osteonic manufactures implants for the CMF, Trauma, Sports Medicine, and Spine categories.

DreamCIS INC.2 shared

Contract research organization providing clinical trial, post-marketing surveillance, and site management services to pharma and medtech clients.

CELLUMED CO., LTD.2 shared

KOSDAQ-listed holding company making medical devices and biologics including bone graft rhBMP2 and knee implant TKR.

HANS BIOMED CORPORATION1 shared

KOSDAQ-listed medical device company producing human tissue implants Bella Cell HD and SureFuse.

SCL Science Inc.1 shared

Founded in 2010 and KOSDAQ-listed in 2019, SCL Science operates medical sealant, bio-logistics, and data platform businesses.

AIOBIO Co., Ltd.1 shared

Develops quantitative fluorescence biomarker technology for oral disease diagnostic devices.

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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