Data / Medical devices / Retainer, Screw Expansion, Orthodontic / South Korea
FDA-registered makers of Retainer, Screw Expansion, Orthodontic in South Korea: 9 establishments
9 establishments in South Korea are registered with the FDA to make Retainer, Screw Expansion, Orthodontic (product code DYJ). 0 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
- Retainer, Screw Expansion, Orthodontic
- Product code
- DYJ
- Country
- South Korea
Makers of Retainer, Screw Expansion, Orthodontic in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Biomaterials Korea Inc. | Hanam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GNI Co., LTD | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mctbio | Yongin-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MK Meditech | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| One Day Dental Partner | Suncheon-si Jeonnam, South Korea | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osteonic Co., Ltd. | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osung MND Co., Ltd. | Gimpo-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SMD Dental Laboratory | Heungdeok-gu Cheongju-si Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smilecad | Dongnae-gu Busan, South Korea | Manufacturer | 0 | 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.