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Medical DevicesKOSPI 14572018 approvals

Founded 2000, KOSPI-listed 2017, Dentium makes dental implants and digital dentistry gear, and is entering the hydrogen fuel cell business.

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Business overview

Source: DART corporate disclosure

Founded in 2000 and listed on KOSPI in 2017, Dentium makes dental implants and dental devices. Products include the Implantium implant brand, Digital Dentistry gear (Rainbow CT), synthetic bone graft (Oesteon), and lab materials (Rainbow Block), forming a Full-Line Up from diagnosis to placement and prosthetics. It also is entering hydrogen fuel cells, localizing SOFC output at a Vietnam plant.

Products & technology

  • Dental implantsDental implant treatment
  • Digital dentistry equipmentCBCT and CAD/CAM digital dental diagnostic and design equipment
  • Synthetic bone graft materialDental synthetic bone graft
  • Lab materialCrowns, etc.
  • Dental procedure suppliesDental procedure supplies

Regulatory approvals

openFDA

18 US FDA 510(k) · 2012–2023

  • FDAbright CT2023-12-14
    510(k) · SpecialRadiologyK231181
  • FDASuperLine2022-02-23
    510(k) · TraditionalDentalK213599
  • FDArainbow MCT2021-04-16
    510(k) · TraditionalRadiologyK200270
  • FDArainbow CT2021-04-16
    510(k) · TraditionalRadiologyK200271
  • FDAiCTmotor (WL-1)2020-09-04
    510(k) · TraditionalDentalK193341
  • FDAIntraoral Sensor2020-06-10
    510(k) · TraditionalRadiologyK201247
  • FDAHealing Abutments and Cover Screws2020-01-23
    510(k) · TraditionalDentalK192436
  • FDAScan Abutments and Comfort Caps2019-11-04
    510(k) · TraditionalDentalK191634
  • FDADentium Implantium & SuperLine Prosthetics2018-05-14
    510(k) · AbbreviatedDentalK172640
  • FDADentium Ti-Base2018-01-11
    510(k) · TraditionalDentalK171622
  • FDAImplantium II2017-09-07
    510(k) · AbbreviatedDentalK171126
  • FDADentium NR Line CAD/CAM Abutments2017-08-17
    510(k) · AbbreviatedDentalK170384
Show 6 more
  • FDASuperLine2017-01-13
    510(k) · AbbreviatedDentalK160965
  • FDADentium CAD/CAM Abutments2016-12-16
    510(k) · TraditionalDentalK161713
  • FDADentium Implantium & SuperLine Prosthetics2016-09-15
    510(k) · AbbreviatedDentalK160828
  • FDABurn-out Cylinder and Angled Screw Abutments2016-08-05
    510(k) · AbbreviatedDentalK160483
  • FDANR Line Implant System2016-07-20
    510(k) · TraditionalDentalK153268
  • FDASIMPLELINE II ABUTMENT SYSTEM2012-01-26
    510(k) · AbbreviatedDentalK112045
Not yet compiled: business overview · R&D. Send us materials and we will add them

Companies in the same categoryMedical Devices

JETEMA Co.,Ltd.90

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i-SENS, Inc.90

Founded in 2000 and KOSDAQ-listed in 2013, i-SENS makes blood glucose monitors and point-of-care testing devices.

SEJONG MEDICAL Co.Ltd.,85

Founded in 2010 and KOSDAQ-listed in 2018, Sejong Medical manufactures laparoscopic surgical instruments.

NanoenTek,Inc.85

Founded in 1987 and listed on KOSDAQ in 2000, NanoenTek develops Lab-On-a-Chip in-vitro diagnostic devices and life science instruments.

Noul Co., Ltd.85

Founded in 2015 and listed on KOSDAQ in 2022, Noul develops the on-device AI diagnostic platform miLab™ for blood and cancer testing.

DRGEM CORPORATION85

KOSDAQ-listed manufacturer of diagnostic X-ray imaging systems and core components such as generators and tubes.

LabGenomics. Co., Ltd.85

KOSDAQ-listed molecular genetic diagnostics company providing NGS-based non-invasive prenatal testing (NIPT) under the MomGuard brand.

Corentec Co., Ltd.85

Founded in 2000 and KOSDAQ-listed in 2013, Corentec makes artificial joints; hip and knee implants exceed 85% of revenue.

OSTEONIC Co., Ltd.85

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

Genesystem Co., Ltd85

Founded 2010, listed on KOSDAQ in 2021, Genesystem develops molecular diagnostic systems, biochips, test kits, and reaction reagents.

SBSUNGBO Co., Ltd.84

Founded in 1961 and KOSPI-listed in 1976, SBSUNGBO makes and sells crop protection agents (fungicides, insecticides, herbicides).

SEEGENE, INC.82

Founded in 2000 and KOSDAQ-listed in 2010, Seegene develops syndromic multiplex PCR molecular diagnostic reagents.

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

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