Data / Medical devices / South Korea / Dentium Co.,ltd(ict Branch)
Dentium Co.,ltd(ict Branch): FDA-registered device maker in Yongin Gyeonggi, South Korea, 4 510(k) clearances
Dentium Co.,ltd(ict Branch) is registered with the FDA (registration 3031093388) in Yongin Gyeonggi, South Korea. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 14, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031093388
- Address
- (16985) 150, Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Yongin Gyeonggi, South Korea, 16985
- Owner or operator
- Dentium Co.,Ltd(ICT branch) (10076095)
- Roles
- Manufacturer
- First device listed
- September 6, 2020
- Registered through
- 2026
- Brand names listed
- bright CT, bright MCT, iCTmotor, rainbow CT, rainbow MCT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Controller, Foot, Handpiece And Cord | EBW | 1 | Manufacturer | accessdata.fda.gov |
| X-Ray, Tomography, Computed, Dental | OAS | 2 | 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 |
|---|---|---|---|---|---|---|
| December 14, 2023 | K231181 | bright CT | OAS | Substantially Equivalent | Dentium Co., Ltd (Ict Branch) | accessdata.fda.gov |
| April 16, 2021 | K200271 | rainbow CT | OAS | Substantially Equivalent | Dentium Co., Ltd (Ict Branch) | accessdata.fda.gov |
| April 16, 2021 | K200270 | rainbow MCT | OAS | Substantially Equivalent | Dentium Co., Ltd (Ict Branch) | accessdata.fda.gov |
| September 4, 2020 | K193341 | iCTmotor (WL-1) | EBW | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 14, 2023. 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.