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Medical DevicesKOSDAQ 261200364 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.

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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

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

  • 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
  • MFDSimplant, endosseous, superstructure2025-11-27
    Product approval · Class 2제인 25-5112 호
Show 68 more
  • 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
  • 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
  • MFDSimplant, endosseous, superstructure2023-09-06
    Product approval · Class 2제인 23-5072 호
  • MFDSimplant, endosseous, superstructure2023-09-06
    Product approval · Class 2제인 23-5071 호

Showing the 80 most recent of 364 records.

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.,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.

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.

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.

OSTEONIC Co., Ltd.11 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.

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.

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.

Ray Co., Ltd.8 shared

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

Sources and updates

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

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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