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Medical DevicesKOSDAQ 261200366 approvals

DENTIS CO.,LTD

Official website

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

As of 2026-10-08, DENTIS CO.,LTD has 333 Korean MFDS device approvals, 33 US FDA clearances/approvals, 10 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

Products & technology

  • Dental implantDental implant classified by fixture screw shape, fixture surface treatment, and abutment connection type
  • Medical LED lighting (LUVIS)LUVIS-branded medical lighting comprising dental treatment lights and surgical shadowless lights
  • Dental 3D printer (ZENITH)ZENITH-branded dental 3D printer line comprising SLA-based ZENITH U and DLP-based ZENITH D
  • BiomaterialsDental synthetic bone graft substitutes and dental membranes

Regulatory approvals

data.go.kr · openFDA

333 Korean MFDS device approvals · 2005–2026 / 33 US FDA 510(k) · 2015–2026

  • MFDSimplant, endosseous, hand instrument2026-09-17
    Product approval · Class 1제신 26-1142 호
  • MFDSLight system, surgical2026-07-31
    Product approval · Class 1제신 26-946 호
  • MFDSImplant, surgical, guide for medical use2026-07-24
    Product approval · Class 2제인 26-4685 호
  • MFDSimplant, endosseous, fixture2026-04-28
    Product approval · Class 3제허 26-317 호
  • MFDSimplant, endosseous, fixture2026-04-01
    Product approval · Class 3제허 26-250 호
  • FDADentis SQ-SL AXEL Fixture2026-03-04
    510(k) · TraditionalDentalK253493
  • MFDSimplant, endosseous, fixture2026-02-10
    Product approval · Class 3제허 26-126 호
  • MFDSimplant, endosseous, fixture2026-02-10
    Product approval · Class 3제허 26-125 호
  • MFDSresin, crown & bridge2026-01-14
    Product approval · Class 2제인 26-4039 호
  • MFDSimplant, endosseous, superstructure2025-12-24
    Product approval · Class 2제인 25-5193 호
  • MFDSimplant, endosseous, superstructure2025-12-12
    Product approval · Class 2제인 25-5157 호
  • MFDSimplant, endosseous, hand instrument2025-12-01
    Product approval · Class 1제신 25-1582 호
Show 68 more
  • MFDSimplant, endosseous, superstructure2025-11-27
    Product approval · Class 2제인 25-5112 호
  • MFDSimplant, endosseous, superstructure2025-11-27
    Product approval · Class 2제인 25-5111 호
  • MFDSimplant, endosseous, hand instrument2025-11-25
    Product approval · Class 1제신 25-1559 호
  • MFDSimplant, endosseous, superstructure2025-11-24
    Product approval · Class 2제인 25-5093 호
  • MFDSimplant, endosseous, hand instrument2025-11-21
    Product approval · Class 1제신 25-1541 호
  • MFDSimplant, endosseous, hand instrument2025-11-21
    Product approval · Class 1제신 25-1539 호
  • MFDSimplant, endosseous, superstructure2025-11-19
    Product approval · Class 2제인 25-5073 호
  • MFDSimplant, endosseous, hand instrument2025-11-19
    Product approval · Class 1제신 25-1527 호
  • MFDSimplant, endosseous, screw driver2025-11-18
    Product approval · Class 1제신 25-1519 호
  • MFDSimplant, endosseous, drill/handpiece2025-11-18
    Product approval · Class 1제신 25-1518 호
  • MFDSattachment, precision2025-11-18
    Product approval · Class 2제인 25-5069 호
  • MFDSimplant, endosseous, hand instrument2025-11-18
    Product approval · Class 1제신 25-1516 호
  • MFDSimplant, endosseous, superstructure2025-11-17
    Product approval · Class 2제인 25-5066 호
  • MFDSimplant, endosseous, superstructure2025-11-17
    Product approval · Class 2제인 25-5065 호
  • MFDSattachment, precision2025-11-17
    Product approval · Class 2제인 25-5064 호
  • MFDSimplant, endosseous, superstructure2025-11-17
    Product approval · Class 2제인 25-5062 호
  • MFDSimplant, endosseous, superstructure2025-11-17
    Product approval · Class 2제인 25-5061 호
  • MFDSimplant, endosseous, superstructure2025-11-17
    Product approval · Class 2제인 25-5060 호
  • MFDSimplant, endosseous, superstructure2025-11-17
    Product approval · Class 2제인 25-5059 호
  • MFDSimplant, endosseous, superstructure2025-11-17
    Product approval · Class 2제인 25-5058 호
  • MFDSimplant, endosseous, superstructure2025-11-17
    Product approval · Class 2제인 25-5057 호
  • MFDSattachment, precision2025-11-14
    Product approval · Class 2제인 25-5054 호
  • MFDSimplant, endosseous, fixture2025-10-28
    Product approval · Class 3제허 25-724 호
  • MFDSimplant, endosseous, fixture2025-10-28
    Product approval · Class 3제허 25-723 호
  • MFDSMeasuring instrument, resonance frequency, dental implant mobility2025-06-16
    Product approval · Class 2제인 25-4517 호
  • MFDSimplant, endosseous, fixture2025-05-23
    Product approval · Class 3제허 25-345 호
  • MFDSimplant, endosseous, superstructure2025-05-21
    Product approval · Class 2제인 25-4433 호
  • MFDSBarrier, intra oral, resorbable2025-05-21
    Product approval · Class 4제허 25-337 호
  • MFDSimplant, endosseous, superstructure2025-04-07
    Product approval · Class 2제인 25-4290 호
  • MFDSLight, examination2025-03-27
    Product approval · Class 1제신 25-388 호
  • FDAChecQ (AC100)2025-03-21
    510(k) · TraditionalDentalK241065
  • MFDSresin, denture, soft, thermoplastic2025-03-20
    Product approval · Class 2제인 25-4217 호
  • MFDSDental chair, patient2025-02-25
    Product approval · Class 1제신 25-206 호
  • MFDSimplant, endosseous, superstructure2025-02-06
    Product approval · Class 2제인 25-4105 호
  • MFDSTable, operation, electrically-powered2024-12-18
    Product approval · Class 1제신 24-1585 호
  • MFDSappliance, orthodontic, resin2024-10-24
    Product approval · Class 2제인 24-964 호
  • MFDSClamp, skull, reusable2024-10-10
    Product approval · Class 1수신 24-1882 호
  • FDALuvis Chair (LC700C)2024-09-06
    510(k) · TraditionalDentalK233921
  • MFDSimplant, endosseous, fixture2024-08-27
    Product approval · Class 3제허 24-584 호
  • MFDSimplant, endosseous, fixture2024-08-26
    Product approval · Class 3제허 24-582 호
  • MFDSappliance, orthodontic, anchor2024-08-20
    Product approval · Class 3제허 24-571 호
  • MFDSimplant, endosseous, fixture2024-08-19
    Product approval · Class 3제허 24-569 호
  • MFDSimplant, endosseous, temporary2024-08-19
    Product approval · Class 3제허 24-568 호
  • MFDSBarrier fixation screw, intra oral, tissue regeneration2024-08-19
    Product approval · Class 3제허 24-567 호
  • MFDSBarrier fixation screw, intra oral, tissue regeneration2024-08-19
    Product approval · Class 3제허 24-566 호
  • MFDSimplant, endosseous, superstructure2024-08-19
    Product approval · Class 2제인 24-787 호
  • MFDSappliance, orthodontic, anchor2024-08-16
    Product approval · Class 3제허 24-559 호
  • FDAs-Clean ScanHealing Abutment2024-07-25
    510(k) · TraditionalDentalK241063
  • MFDSimplant, endosseous, drill/handpiece2024-07-05
    Product approval · Class 1제신 24-838 호
  • MFDSPatient positioning or immobilization device2024-05-27
    Product approval · Class 1수신 24-953 호
  • FDADentis s-Clean SQ-SL Fixture2024-05-20
    510(k) · TraditionalDentalK240511
  • MFDSMedical image, analog to digital transform, dentalRevoked2024-03-14
    Product approval · Class 2수인 24-116 호
  • MFDSMedical image, analog to digital transform, dentalRevoked2024-03-14
    Product approval · Class 2수인 24-122 호
  • FDAMESHEET2024-02-22
    510(k) · TraditionalDentalK233544
  • MFDSimplant, endosseous, superstructure2024-02-22
    Product approval · Class 2제인 24-193 호
  • MFDSLight, examination2024-02-21
    Product approval · Class 1제신 24-223 호
  • MFDSDental chair, patient2024-01-17
    Product approval · Class 1제신 24-76 호
  • MFDSimplant, endosseous, superstructure2024-01-09
    Product approval · Class 2제인 24-31 호
  • MFDSLight system, surgical2024-01-09
    Product approval · Class 1제신 24-34 호
  • MFDSTable, operation, electrically-powered2024-01-08
    Product approval · Class 1제신 24-26 호
  • MFDSPatient positioning or immobilization device2023-12-22
    Product approval · Class 1수신 23-2951 호
  • MFDSLight, examinationRevoked2023-12-22
    Product approval · Class 1제신 23-1801 호
  • MFDSLight, dental, general-purpose2023-12-20
    Product approval · Class 1제신 23-1787 호
  • MFDSDental image, treatment planning software2023-12-19
    Product approval · Class 2제인 23-5372 호
  • MFDSProduct name not recorded2023-12-19
    Product approval · Class 2인 23-5372 호
  • MFDSattachment, precision2023-10-12
    Product approval · Class 2제인 23-5161 호
  • MFDSattachment, precision2023-10-12
    Product approval · Class 2제인 23-5160 호
  • MFDSimplant, endosseous, superstructure2023-09-06
    Product approval · Class 2제인 23-5073 호

Showing the 80 most recent of 366 records.

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 172 more patents

AI reads

MAA server logs · IP-verified
123
Times AI engines pulled DENTIS 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.

2
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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.

121
Index crawls

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0
Direct AI-tool queries (MCP)

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

13
live 0
Last 7 days
102
live 2
Last 30 days
123
live 2
All time
  • OpenAIChatGPT-Userlive2
  • OpenAIOAI-SearchBot99
  • GoogleGoogleOther14
  • PerplexityPerplexityBot5
  • 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.,LTD46 shared

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

DIO Corporation31 shared

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

YUHAN CORPORATION24 shared

Founded in 1926 and listed on the KOSPI in 1962, Yuhan Corporation is a comprehensive pharmaceutical company known for its innovative drug Leclaza.

Alpha AI Co.,Ltd.19 shared

Alpha AI, founded in 1995 and KOSDAQ-listed in 2000, manufactures biocompatible metal implants and surgical instruments.

Corentec Co., Ltd.15 shared

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

CG MedTech Co.,Ltd.15 shared

Founded in 1997 and KOSDAQ-listed in 2015, CG MedTech makes orthopedic medical devices and also operates an electric energy business.

Ray Co., Ltd.12 shared

KOSDAQ-listed dental medical device company offering the RAYSCAN digital diagnostic system and RAYDENT digital treatment solutions.

OSTEONIC Co., Ltd.12 shared

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

WSI Co., Ltd.10 shared

Founded and KOSDAQ-listed in 2018, WSI distributes spine/joint devices and has expanded into medical robots and pharma via subsidiaries.

MEDYSSEY CO.,LTD9 shared

Manufactures spinal implants and metal 3D-printed patient-specific implants, exporting to over 25 countries.

L&K BIOMED CO., LTD.8 shared

Spinal implant device maker founded 2008, listed on KOSDAQ 2016; produces Cervical and Thoraco Lumbar Cage, Screw, and Plate products.

JW PHARMACEUTICAL8 shared

Founded in 1945, JW Pharmaceutical holds an original drug pipeline including Rivalo and Hemlibra, plus the IV nutrition product Winuf and OTC brand Hwakol.

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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