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Data / Medical devices / Implant, Endosseous, Root-Form / South Korea

FDA-registered makers of Implant, Endosseous, Root-Form in South Korea: 42 establishments

42 establishments in South Korea are registered with the FDA to make Implant, Endosseous, Root-Form (product code DZE). 42 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Get makers of this device in South KoreaWatch these makers
Device
Implant, Endosseous, Root-Form
Product code
DZE
Country
South Korea

Makers of Implant, Endosseous, Root-Form in South Korea

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Osstem Implant Co., Ltd.Gangseo-gu Seoul, South KoreaSpecification developer29September 23, 2023000api.fda.gov
MegaGen Implant Co., Ltd. (Research Laboratories)Daegu, South KoreaSpecification developer22June 18, 2026000api.fda.gov
Megagen Implant Co., Ltd.Daegu, South KoreaManufacturer22June 18, 2026000api.fda.gov
Dentis Co., Ltd.Daegu, South KoreaManufacturer19March 4, 2026000api.fda.gov
Osstem Implant Co., Ltd.Haeundae-gu Busan, South KoreaManufacturer19September 23, 2023000api.fda.gov
KJ Meditech Co., Ltd.Gwangju, South KoreaContract manufacturer, Manufacturer16March 1, 2022000api.fda.gov
DIO CorporationHaeundae-gu Busan, South KoreaManufacturer14December 14, 2018000api.fda.gov
Neobiotech Co., Ltd.Wonju-si Gangwon, South KoreaManufacturer10March 28, 2024000api.fda.gov
Innobiosurg Co., Ltd.Daejeon, South KoreaManufacturer9December 20, 2022000api.fda.gov
ARUM DENTISTRY Co., Ltd.Yuseong-gu Daejeon, South KoreaManufacturer7July 23, 2025000api.fda.gov
Biotem Co., Ltd.Busan, South KoreaManufacturer6June 24, 2023000api.fda.gov
Izenimplant Co., Ltd.Pyeongtaek-si Gyeonggi, South KoreaManufacturer6March 16, 2026000api.fda.gov
Dentium Co., Ltd.Suwon-si Gyeonggi, South KoreaManufacturer5February 23, 2022000api.fda.gov
Izenimplant Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer5March 16, 2026000api.fda.gov
Shinhung MST Co., Ltd.Wonju Si Gangwon, South KoreaManufacturer5June 4, 2023000api.fda.gov
ACH Medical Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer4April 3, 2018000api.fda.gov
CSM ImplantDaegu, South KoreaManufacturer4September 19, 2018000api.fda.gov
Evidence Implant Inc.Daegu, South KoreaContract manufacturer, Manufacturer4January 22, 2020000api.fda.gov
TruAbutment Korea Co., Ltd.Bucheon-si Gyeonggi, South KoreaManufacturer4July 3, 2025000api.fda.gov
Cowellmedi Co., Ltd.Busan, South KoreaManufacturer3December 27, 2024000api.fda.gov
Medimecca Co LtdSeoul, South KoreaManufacturer3September 25, 2020000api.fda.gov
Ossvis Co., Ltd.Anyang-si Gyeonggi, South KoreaManufacturer3November 7, 2024000api.fda.gov
Idis Co., Ltd.Bucheon-si Gyeonggi, South KoreaManufacturer2April 11, 2024000api.fda.gov
Oneday Biotech Co., Ltd.Daegu, South KoreaManufacturer2August 23, 2023000api.fda.gov
Sewon Medix, Inc.Busan, South KoreaManufacturer2July 7, 2023000api.fda.gov
Snucone Co., Ltd.Dalseo-gu Daegu, South KoreaManufacturer2June 8, 2023000api.fda.gov
WARANTEC Co., Ltd.Seongnam-si Gyeonggi, South KoreaManufacturer2June 18, 2018000api.fda.gov
Zeros Co., Ltd.Gimhae-si Gyeongnam, South KoreaManufacturer2August 19, 2026000api.fda.gov
8dent Inc.Gimhae-si Gyeongnam, South KoreaManufacturer1May 24, 2024000api.fda.gov
Cybermed Inc.Daejeon, South KoreaManufacturer1January 7, 2022000api.fda.gov
Daekwang I.D.MSeoul, South KoreaManufacturer1March 21, 2014000api.fda.gov
Denq Co., Ltd.Busan, South KoreaManufacturer1September 13, 2024000api.fda.gov
Dentos, IncorporatedDaegu, South KoreaManufacturer1May 16, 2006000api.fda.gov
DIMPLO Ltd.Yeonje-gu Busan, South KoreaManufacturer1December 22, 2025000api.fda.gov
Dentis Co.,LtdDong-gu Daegu, South KoreaManufacturer1March 4, 2026000api.fda.gov
Eclectic Inc.Hwaseong-si Gyeonggi, South KoreaManufacturer1May 24, 2024000api.fda.gov
F&B Technology Co., Ltd.Sasang-ku Busan, South KoreaManufacturer1June 19, 2020000api.fda.gov
Highness Co.,ltd.Gyeongsangbuk-do Gyeongbuk, South KoreaManufacturer1October 31, 2024000api.fda.gov
Jeil Medical CorporationSeoul, South KoreaManufacturer1February 24, 2004000api.fda.gov
POINTIMPLANT Co., LtdBusan, South KoreaComplaint file establishment, Manufacturer1April 13, 2023000api.fda.gov
T. Strong Inc.Gimhae-si Gyeongnam, South KoreaManufacturer1June 5, 2014000api.fda.gov
Unidental.co.krGwangmyeong-si Gyeonggi, South KoreaManufacturer1October 25, 2023000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.