Data / Medical devices / Material, Impression / South Korea
FDA-registered makers of Material, Impression in South Korea: 13 establishments
13 establishments in South Korea are registered with the FDA to make Material, Impression (product code ELW). 13 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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- Device
- Material, Impression
- Product code
- ELW
- Country
- South Korea
Makers of Material, Impression in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Vericom Co., Ltd. | Chuncheon-Si Gangwon, South Korea | Manufacturer | 5 | November 3, 2016 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | Specification developer | 4 | March 18, 2021 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | SIHEUNG Gyeonggi, South Korea | Manufacturer | 4 | March 18, 2021 | 0 | 0 | 0 | api.fda.gov |
| Diadent Group International | CHONGJU CITY Chungbuk, South Korea | Manufacturer | 3 | September 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Handae Chemical Co., Ltd | Jincheon-gun Chungbuk, South Korea | Manufacturer, Repackager or relabeler | 2 | August 15, 2014 | 0 | 0 | 0 | api.fda.gov |
| HRS Co., Ltd. | Pyongtaek Gyeonggi, South Korea | Manufacturer | 2 | November 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| B&e Korea Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 1 | February 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Dentkist, Inc. | Gunpo-si Gyeonggi, South Korea | Manufacturer | 1 | March 8, 2016 | 0 | 0 | 0 | api.fda.gov |
| GENOSS Co., Ltd. | Suwon-si Gyeonggi, South Korea | Manufacturer | 1 | December 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| Hdi Inc. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | November 7, 2022 | 0 | 0 | 0 | api.fda.gov |
| Seilglobal Co., Ltd | Busan Gyeongnam, South Korea | Manufacturer | 1 | February 23, 2015 | 0 | 0 | 0 | api.fda.gov |
| Sherpa Korea | Saha-gu Busan, South Korea | Manufacturer | 1 | February 11, 2011 | 0 | 0 | 0 | api.fda.gov |
| Spident Co., Ltd. | INCHEON Gyeonggi, South Korea | Manufacturer | 1 | September 30, 2016 | 0 | 0 | 0 | api.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.