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Data / Medical devices / Abutment, Implant, Dental, Endosseous / South Korea

FDA-registered makers of Abutment, Implant, Dental, Endosseous in South Korea: 44 establishments

44 establishments in South Korea are registered with the FDA to make Abutment, Implant, Dental, Endosseous (product code NHA). 28 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.

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Device
Abutment, Implant, Dental, Endosseous
Product code
NHA
Country
South Korea

Makers of Abutment, Implant, Dental, Endosseous in South Korea

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Osstem Implant Co., Ltd.Gangseo-gu Seoul, South KoreaSpecification developer21January 29, 2026000api.fda.gov
Osstem Implant Co., Ltd.Haeundae-gu Busan, South KoreaComplaint file establishment, Contract manufacturer, Manufacturer16March 4, 2026000api.fda.gov
Dentis Co., Ltd.Daegu, South KoreaManufacturer13July 25, 2024000api.fda.gov
TruAbutment Korea Co., Ltd.Bucheon-si Gyeonggi, South KoreaManufacturer13October 9, 2024000api.fda.gov
Dentium Co., Ltd.Suwon-si Gyeonggi, South KoreaManufacturer11January 23, 2020000api.fda.gov
MegaGen Implant Co., Ltd. (Research Laboratories)Daegu, South KoreaSpecification developer9January 13, 2025000api.fda.gov
Megagen Implant Co., Ltd.Daegu, South KoreaManufacturer9January 13, 2025000api.fda.gov
ARUM DENTISTRY Co., Ltd.Yuseong-gu Daejeon, South KoreaManufacturer6November 25, 2024000api.fda.gov
DIO CorporationHaeundae-gu Busan, South KoreaManufacturer5August 18, 2023000api.fda.gov
Innobiosurg Co., Ltd.Daejeon, South KoreaManufacturer5August 25, 2021000api.fda.gov
Cowellmedi Co., Ltd.Busan, South KoreaManufacturer4September 16, 2025000api.fda.gov
Ossvis Co., Ltd.Anyang-si Gyeonggi, South KoreaManufacturer4December 5, 2024000api.fda.gov
Simda Co.,ltd.Busan, South KoreaManufacturer3December 18, 2025000api.fda.gov
Geomedi Co., Ltd.Uiwang-si, Gyeonggi, South KoreaContract manufacturer, Exporter to the US, Manufacturer2June 16, 2025000api.fda.gov
Izenimplant Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer2January 12, 2024000api.fda.gov
Izenimplant Co., Ltd.Pyeongtaek-si Gyeonggi, South KoreaManufacturer2January 12, 2024000api.fda.gov
Neobiotech Co., Ltd.Wonju-si Gangwon, South KoreaManufacturer2April 30, 2024000api.fda.gov
SMD Dental LaboratoryHeungdeok-gu Cheongju-si Chungbuk, South KoreaManufacturer2February 21, 2025000api.fda.gov
Shinhung MST Co., Ltd.Wonju Si Gangwon, South KoreaManufacturer2February 3, 2023000api.fda.gov
WARANTEC Co., Ltd.Seongnam-si Gyeonggi, South KoreaManufacturer2October 2, 2023000api.fda.gov
ACH Medical Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer1August 6, 2021000api.fda.gov
Allonus Tech Co., Ltd.Yangsan-si Gyeongnam, South KoreaManufacturer1December 17, 2024000api.fda.gov
Daekwang I.D.MSeoul, South KoreaManufacturer1August 8, 2012000api.fda.gov
Eclectic Inc.Hwaseong-si Gyeonggi, South KoreaManufacturer1October 18, 2024000api.fda.gov
KJ Meditech Co., Ltd.Gwangju, South KoreaContract manufacturer, Manufacturer1August 8, 2012000api.fda.gov
Oneday Biotech Co., Ltd.Daegu, South KoreaManufacturer1February 21, 2024000api.fda.gov
Surgident Co., Ltd.Dong-gu Daegu, South KoreaManufacturer1May 17, 2019000api.fda.gov
Zeros Co., Ltd.Gimhae-si Gyeongnam, South KoreaManufacturer1July 28, 2025000api.fda.gov
8dent Inc.Gimhae-si Gyeongnam, South KoreaManufacturer0000api.fda.gov
Biotem Co., Ltd.Busan, South KoreaManufacturer0000api.fda.gov
CSM ImplantDaegu, South KoreaManufacturer0000api.fda.gov
Cybermed Inc.Daejeon, South KoreaManufacturer0000api.fda.gov
Denq Co., Ltd.Busan, South KoreaManufacturer0000api.fda.gov
DIMPLO Ltd.Yeonje-gu Busan, South KoreaManufacturer0000api.fda.gov
Evidence Implant Inc.Daegu, South KoreaContract manufacturer, Manufacturer0000api.fda.gov
F&B Technology Co., Ltd.Sasang-ku Busan, South KoreaManufacturer0000api.fda.gov
Highness Co.,ltd.Gyeongsangbuk-do Gyeongbuk, South KoreaManufacturer0000api.fda.gov
Idis Co., Ltd.Bucheon-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Medimecca Co LtdSeoul, South KoreaManufacturer0000api.fda.gov
POINTIMPLANT Co., LtdBusan, South KoreaComplaint file establishment, Manufacturer0000api.fda.gov
Sewon Medix, Inc.Busan, South KoreaManufacturer0000api.fda.gov
Snucone Co., Ltd.Dalseo-gu Daegu, South KoreaManufacturer0000api.fda.gov
T. Strong Inc.Gimhae-si Gyeongnam, South KoreaManufacturer0000api.fda.gov
Unidental.co.krGwangmyeong-si Gyeonggi, South KoreaManufacturer0000api.fda.gov

Updated November 3, 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.