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Medical DevicesKONEX 44769029 approvals

AIOBIO Co., Ltd.

Official website

Develops quantitative fluorescence biomarker technology for oral disease diagnostic devices.

As of 2026-10-10, AIOBIO Co., Ltd. has 27 Korean MFDS device approvals, 2 US FDA clearances/approvals, 1 PubMed-indexed paper on record (counted by the MAA Company Index from its own matching of public databases).

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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

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 31 more patents

AI reads

MAA server logs · IP-verified
46
Times AI engines pulled AIOBIO Co., Ltd.'s records

Pulled records become part of each AI's index and keep feeding its answers. When an AI cites from that index, nothing reaches our server — so actual citations are uncounted here and exceed this number.

0
Fetched fresh mid-answer

Times an AI needed something not yet in its index and fetched this page fresh while answering. Citations served from the index leave no trace here.

46
Index crawls

Collected as raw material for future answers.

0
Direct AI-tool queries (MCP)

Queries from users who connected this index to their own AI.

23
live 0
Last 7 days
39
live 0
Last 30 days
46
live 0
All time
  • OpenAIOAI-SearchBot36
  • PerplexityPerplexityBot4
  • GoogleGoogleOther3
  • AnthropicClaudeBot2
  • MicrosoftBingbot1

Measured since Aug 27, 2026 · 5 AI engines · last read Oct 8, 2026

User-agent strings can be forged, so we do not count them at face value. We count only requests matched against vendor-published IP ranges, or confirmed by forward-verified reverse DNS. MCP queries are actual calls to this index's tool endpoint.

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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.,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.

Synergy Innovation Co., Ltd.1 shared

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

REMEDI Inc.1 shared

Founded in 2012 and listed on KOSDAQ in 2026, REMEDI develops portable X-ray imaging devices based on its low-dose, miniaturized X-ray technology.

DONGSUNG PHARMACEUTICAL CO.,LTD1 shared

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

Micro-NX Co., Ltd.1 shared

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

NIBEC CO., LTD.1 shared

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

Optipharm.CO.,LTD1 shared

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

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

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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