Data / Medical devices / South Korea / Oneday Biotech Co., Ltd.
Oneday Biotech Co., Ltd.: FDA-registered device maker in Daegu, South Korea, 3 510(k) clearances
Oneday Biotech Co., Ltd. is registered with the FDA (registration 3017548645) in Daegu, South Korea. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017548645
- Address
- 135 C Seongseodongro Dalseogu, Daegu, South Korea, 42721
- Owner or operator
- Oneday Biotech Co., Ltd. (10078125)
- Roles
- Manufacturer
- First device listed
- October 11, 2020
- Registered through
- 2026
- Brand names listed
- 1.2 Hex Driver for Ratchet, 1.25 Hex Driver for Ratchet, Bone Expander, Complete Kit (KIT001, KIT002), Depth Pin, Digital Lab Analog, Digital Multi Unit Analog, Drill Extension and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | 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 |
|---|---|---|---|---|---|---|
| February 21, 2024 | K231753 | Oneday Implant Abutment | NHA | Substantially Equivalent | Oneday Biotech Co., Ltd. | accessdata.fda.gov |
| August 23, 2023 | K222946 | Oneday Mini Implant System | DZE | Substantially Equivalent | Oneday Biotech Co., Ltd. | accessdata.fda.gov |
| July 31, 2020 | K192294 | I Do | DZE | Substantially Equivalent | I DO Biotech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
Updated February 21, 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.