Data / Medical devices / South Korea / Idis Co., Ltd.
Idis Co., Ltd.: FDA-registered device maker in Bucheon-si Gyeonggi, South Korea, 2 510(k) clearances
Idis Co., Ltd. is registered with the FDA (registration 3026365523) in Bucheon-si Gyeonggi, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 11, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3026365523
- Address
- #1314 ~ #1319, 122, Jomaru-ro, 385 beon gil, Bucheon-si Gyeonggi, South Korea, 14556
- Owner or operator
- IDIS Co. Ltd. (10089789)
- Roles
- Manufacturer
- First device listed
- January 8, 2024
- Registered through
- 2026
- Brand names listed
- Ni2 Implant System, S-Plant Dental Implant System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 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 11, 2024 | K221847 | Ni2 Implant System | DZE | Substantially Equivalent | Newton Implant Systems, Inc. | accessdata.fda.gov |
| December 18, 2023 | K231429 | S-Plant Dental Implant System | DZE | Substantially Equivalent | Idis Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 11, 2024. 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.