Data / Medical devices / South Korea / DMS Co., Ltd.
DMS Co., Ltd.: FDA-registered device maker in Wonju-si Gangwon, South Korea, 1 510(k) clearance
DMS Co., Ltd. is registered with the FDA (registration 3014330970) in Wonju-si Gangwon, South Korea. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 20, 2019. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3014330970
- Address
- 4 dong-#107, 201, 202, 42-10, Taejanggongdan-gil, Wonju-si Gangwon, South Korea, 26311
- Owner or operator
- DMS Co., Ltd. (10057141)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- February 28, 2018
- Registered through
- 2027
- Brand names listed
- AnyCheck Barrier Sleeve, AnyCheck IMT-100, Dr. Plant, VAROGuide PreGuide
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Manufacturer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 20, 2019 | K180953 | AnyCheck IMT-100 | EKX | Substantially Equivalent | Dms Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Handpiece, Direct Drive, Ac-Powered
- All makers of Toothbrush, Powered
- All makers of Bedding, Disposable, Medical
- All makers of Accessories, Implant, Dental, Endosseous
Updated February 20, 2019. 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.