Data / Medical devices / South Korea / F&B Technology Co., Ltd.
F&B Technology Co., Ltd.: FDA-registered device maker in Sasang-ku Busan, South Korea, 1 510(k) clearance
F&B Technology Co., Ltd. is registered with the FDA (registration 3018077122) in Sasang-ku Busan, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 19, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018077122
- Address
- 92-3, Saebyeoksijang-Ro, Sasang-ku Busan, South Korea, 46987
- Owner or operator
- F&B Technology Co., Ltd. (10080055)
- Roles
- Manufacturer
- First device listed
- January 10, 2021
- Registered through
- 2026
- Brand names listed
- Fit & Brilliant 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 |
|---|---|---|---|---|---|---|
| June 19, 2020 | K190637 | Fit & Brilliant Dental Implant System | DZE | Substantially Equivalent | F&B Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 19, 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.