Data / Medical devices / South Korea / Ids Korea
Ids Korea: FDA-registered device maker in Seoul, South Korea, 2 510(k) clearances
Ids Korea is registered with the FDA (registration 3007160911) in Seoul, South Korea. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 11, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007160911
- Address
- 10, Gwangnaru-ro 8-gil, Seongdong-Gu 503, Ace Seongsu Tower 1, Seoul, South Korea, 04799
- Owner or operator
- IDS Korea (10027020)
- Roles
- Manufacturer
- First device listed
- September 16, 2008
- Registered through
- 2026
- Brand names listed
- Dentsply, E-MAX Crown, Nobel Biocare, Porcelain Fused to Metal Crown, Porcelain Powder, Ticonium
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Crown, Preformed | ELZ | 1 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 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 |
|---|---|---|---|---|---|---|
| October 11, 2019 | K191902 | Razor, Everest, U&C Liquid | EIH | Substantially Equivalent | U&C International Co., Ltd. | accessdata.fda.gov |
| December 15, 2014 | K143330 | BruxZir Anterior | EIH | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- All makers of Powder, Porcelain
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Crown, Preformed
Updated October 11, 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.