Manufacturer registered with FDA
Dentium Co.,Ltd(ICT branch)
Suwon, South Korea. Lists 3 dental device types with FDA across 2 registered establishments, and holds 3 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 7
- 510(k) clearances
- 32021–2023
- Markets registered in
- 519 registrations outside the US
- Establishments
- 2South Korea
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Dentium Co.,Ltd(ICT branch) 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 | Dentium Co.,Ltd(ICT branch) | 3 clearances | 2021–2023 | Below |
| Taiwan | TFDA | Manufacturer | Dentium Co., Ltd. (ICT Branch)DENTIUM CO. LTD. (ICT BRANCH) · Dentium Co., Ltd (ICT Branch) | 10 | 2016–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Dentium Co., Ltd. (ICT Branch) | 7 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Dentium Co., Ltd. (ICT Branch) | 1 | 2026–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Dentium Co., Ltd. (ICT Branch) | 1 | — | 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 Dentium Co.,Ltd(ICT branch) currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | bright CTbright MCTrainbow CTrainbow MCT | 2021 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | iCTmotor | 2020 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | IOX1IOX2 | 2020 |
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 Dentium Co.,Ltd(ICT branch) as the applicant.
Also lists devices cleared under other names
Dentium Co.,Ltd(ICT branch) lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dentium USA (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 4 Sep 2020 | K193341 | iCTmotor (WL-1) | Dentium USA | EBW Handpiece and Cord Foot Controller |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTIUM CO.,LTD(ICT BRANCH)FDA reg. 3017403245 | Suwon Gyeonggi, South Korea | Manufacturer |
| DENTIUM CO.,LTD(ICT BRANCH)FDA reg. 3031093388 | Yongin Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10076095). 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.