Data / Medical devices / Needle, Dental / South Korea
FDA-registered makers of Needle, Dental in South Korea: 11 establishments
11 establishments in South Korea are registered with the FDA to make Needle, Dental (product code DZM). 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
- Needle, Dental
- Product code
- DZM
- Country
- South Korea
Makers of Needle, Dental in South Korea
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| B&L Biotech Co., Inc | Ansan City Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C-K Dental Ind. Co., Ltd. | Bucheon-Si, Gyeonggi-Do, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Studio | Anyang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maruchi | Wonju-si Gangwon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mctbio | Yongin-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osstem Implant Co., Ltd. | Haeundae-gu Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shinhung Co. Ltd. | Ansan-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smeng Co.,ltd. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spident Co., Ltd. | INCHEON Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sungshim Medicare Co.,Ltd. | Anseong-si Gyeonggi, 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.