Data / Medical devices / South Korea / 8dent Inc.
8dent Inc.: FDA-registered device maker in Gimhae-si Gyeongnam, South Korea, 1 510(k) clearance
8dent Inc. is registered with the FDA (registration 3033519161) in Gimhae-si Gyeongnam, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 24, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033519161
- Address
- 20-13, Seogimhaesandan-ro, Gimhae-si Gyeongnam, South Korea, 50967
- Owner or operator
- 8dent Inc. (10091412)
- Roles
- Manufacturer
- First device listed
- September 29, 2024
- Registered through
- 2026
- Brand names listed
- 8plant Implant System - BM3508, 8plant Implant System - BM3510, 8plant Implant System - BM3511, 8plant Implant System - BM3513, 8plant Implant System - BR4007, 8plant Implant System - BR4007N, 8plant Implant System - BR4008, 8plant Implant System - BR4008N and more
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 |
|---|---|---|---|---|---|---|
| May 24, 2024 | K231426 | 8plant Implant System | DZE | Substantially Equivalent | Hoowon Edi Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 24, 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.