Manufacturer registered with FDA
DMS Co., Ltd.
Wonju-si, South Korea. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 12019–2019
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name DMS Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | DMS Co., Ltd. | 1 clearances | 2019–2019 | Below |
| Taiwan | TFDA | Manufacturer | DMS CO., LTD. | 1 | 2022–2022 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What DMS Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | AnyCheck IMT-100 | 2020 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Dr. Plant | 2018 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | VAROGuide PreGuide | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names DMS Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 20 Feb 2019 | K180953 | AnyCheck IMT-100 | EKX Ac-Powered Direct Drive Handpiece |
Some of these clearances are listed with FDA today by another company: Neobiotech Co., Ltd. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DMS CO., LTD.FDA reg. 3014330970 | Wonju-si Gangwon, South Korea | Complaint file establishment, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10057141). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.