Data / Medical devices / South Korea / Highness Co.,ltd.
Highness Co.,ltd.: FDA-registered device maker in Gyeongsangbuk-do Gyeongbuk, South Korea, 1 510(k) clearance
Highness Co.,ltd. is registered with the FDA (registration 3031462380) in Gyeongsangbuk-do Gyeongbuk, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 31, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031462380
- Address
- 98-10, Hyeondae-ro, Waegwan-eup, Chilgok-gun, Gyeongsangbuk-do Gyeongbuk, South Korea, 39871
- Owner or operator
- highness Co.,Ltd. (10093674)
- Roles
- Manufacturer
- First device listed
- June 20, 2025
- Registered through
- 2026
- Brand names listed
- HIGHNESS 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 |
|---|---|---|---|---|---|---|
| October 31, 2024 | K240383 | Highness Implant System | DZE | Substantially Equivalent | Highness Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 31, 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.