Medical AI Alliance
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Medical DevicesKONEX 44769029 approvals

AIOBIO Co., Ltd.

Official website

Develops quantitative fluorescence biomarker technology for oral disease diagnostic devices.

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 2011 and listed on KONEX in 2022, AIOBIO is an oral healthcare company. It has developed optical digital biomarker technology that quantitatively analyzes natural fluorescence signals from dental plaque and oral tissue to detect lesions and functional changes, and manufactures diagnostic devices, AI software, and oral care products based on this technology. It supplies products domestically and internationally across four business segments: medical devices, software/platform, personal oral examination devices, and oral care products/treatment materials.

Products & technology

  • Oral disease diagnostic deviceEarly detection of oral lesions and functional changes via quantitative fluorescence biomarker
  • AI softwareOral diagnostic data analysis
  • Personal oral examination devicePersonal oral examination
  • Oral care products/treatment materialsOral care and treatment

Regulatory approvals

data.go.kr · openFDA

27 Korean MFDS device approvals · 2012–2026 / 2 US FDA 510(k) · 2019–2024

  • MFDSLight, dental, general-purpose2026-02-10
    Product approval · Class 1제신 26-202 호
  • MFDSDevice, caries detection, optical2024-11-15
    Product approval · Class 2제인 24-1027 호
  • MFDSDevice, caries detection, optical2024-11-07
    Product approval · Class 2제인 24-998 호
  • MFDSDental image, Picture archiving and communication system, software, class 12024-10-30
    Product approval · Class 1제신 24-1327 호
  • FDAQraycam PRO2024-09-04
    510(k) · TraditionalDentalK221275
  • MFDSStomatoscope, video2024-07-10
    Product approval · Class 1제신 24-868 호
  • MFDSDental image, Picture archiving and communication system, software, class 12024-07-10
    Product approval · Class 1제신 24-855 호
  • MFDSDental image, Picture archiving and communication system, software, class 12024-06-10
    Product approval · Class 1제신 24-705 호
  • MFDSStomatoscope, video2024-04-04
    Product approval · Class 1제신 24-398 호
  • MFDSDevice, caries detection, optical2023-09-19
    Product approval · Class 2제인 23-5103 호
  • MFDSDental mirror2020-09-21
    Product approval · Class 1제신 20-1437 호
  • MFDSDental mirror2020-09-10
    Product approval · Class 1제신 20-1396 호
Show 17 more
  • MFDSDental mirror2019-09-16
    Product approval · Class 1제신 19-1213 호
  • MFDSDevice, caries detection, optical2019-08-30
    Product approval · Class 2제인 19-4729 호
  • MFDSDental mirror2019-08-02
    Product approval · Class 1제신 19-1052 호
  • FDAQraypen2019-07-18
    510(k) · TraditionalDentalK183121
  • MFDSDevice, caries detection, optical2019-03-26
    Product approval · Class 2제인 19-4224 호
  • MFDSDevice, caries detection, optical2018-01-04
    Product approval · Class 2제인 18-4005 호
  • MFDSDevice, caries detection, optical2017-12-19
    Product approval · Class 2제인 17-4982 호
  • MFDSStomatoscope, video2017-06-02
    Product approval · Class 1제신 17-594 호
  • MFDSMouth gag2017-05-26
    Product approval · Class 1제신 17-558 호
  • MFDSLight, dental, general-purpose2017-05-23
    Product approval · Class 1제신 17-528 호
  • MFDSDental polymerization activator- visible light2017-04-11
    Product approval · Class 1제신 17-372 호
  • MFDSStomatoscope, video2015-05-18
    Product approval · Class 1서울 제신 15-175 호
  • MFDSIVD reagents for staining or culturing clinical microbiology2014-10-20
    Product approval · Class 1서울 체외 제신 14-410 호
  • MFDSLight, dental, general-purpose2014-05-23
    Product approval · Class 1서울 제신 14-244 호
  • MFDSStomatoscope, video2014-01-23
    Product approval · Class 1서울 제신 14-53 호
  • MFDSLight, dental, general-purpose2012-06-21
    Product approval · Class 1경인 제신 12-209 호
  • MFDSSystem, medical image processing device2012-02-15
    Product approval · Class 1경인 제신 12-41 호
Not yet compiled: business overview · R&D. Send us materials and we will add them

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.,LTD6 shared

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

DENTIS CO.,LTD2 shared

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

REMEDI Inc.1 shared
Synergy Innovation Co., Ltd.1 shared

Synergy Innovation, founded in 1998 and KOSDAQ-listed in 2004, manufactures and sells microbial culture media.

Optipharm.CO.,LTD1 shared

Optipharm, founded in 2000 and KOSDAQ-listed in 2018, provides animal disease diagnostics, animal medicine, and biotech.

Micro-NX Co., Ltd.1 shared

Micro-NX develops proprietary BLDC motor technology and manufactures dental medical devices including implant engines and torque drivers.

DONGSUNG PHARMACEUTICAL CO.,LTD1 shared

Founded in 1957 and listed on KOSPI in 1990, Dongsung Pharmaceutical runs pharmaceutical, hair-dye, and cosmetics business segments.

NIBEC CO., LTD.1 shared

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

GC Medical Science Corporation1 shared

GC Medical Science Corporation, KOSDAQ-listed since 2014, operates diagnostic reagent, blood glucose, and hemodialysis solution businesses.

MITECH CO.,LTD.1 shared

MITECH CO.,LTD., founded in 1991 and listed on KOSDAQ in 2018, makes non-vascular stents and distributes Fujifilm endoscopy equipment.

QuantaMatrix Incorporated1 shared

Established in 2010, listed on KOSDAQ in 2020, QuantaMatrix develops dRAST and QDST antimicrobial susceptibility testing systems.

CLASSYS Inc.1 shared

CLASSYS Inc., established in 2015 and listed on KOSDAQ, makes aesthetic medical devices using HIFU, MRF, MNRF, and laser technologies.

Sources and updates

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

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