Data / Medical devices / South Korea / 3D Industrial Imaging Co., Ltd.
3D Industrial Imaging Co., Ltd.: FDA-registered device maker in Seoul, South Korea, 4 510(k) clearances
3D Industrial Imaging Co., Ltd. is registered with the FDA (registration 3004755841) in Seoul, South Korea. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated April 10, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004755841
- Address
- 412 & 413 Institute of Computer Technology Seoul National University, Daehak-dong, Seoul, South Korea, 08826
- Owner or operator
- 3D Industrial Imaging Co., Ltd. (10052838)
- Roles
- Manufacturer
- First device listed
- October 11, 2016
- Registered through
- 2026
- Brand names listed
- Dentiq3D, DentiqAir, DentiqGuide, PYLON, VARO Plan
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| April 10, 2020 | K200078 | VARO Plan | LLZ | Substantially Equivalent | 3D Industrial Imaging Co., Ltd. | accessdata.fda.gov |
| December 19, 2019 | K183676 | DentiqAir | LLZ | Substantially Equivalent | 3D Industrial Imaging Co., Ltd. | accessdata.fda.gov |
| July 19, 2018 | K180629 | DentiqGuide | LLZ | Substantially Equivalent | 3D Industrial Imaging Co., Ltd. | accessdata.fda.gov |
| October 5, 2016 | K160666 | Dentiq3D | LLZ | Substantially Equivalent | 3D Industrial Imaging Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 10, 2020. 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.