Data / Medical devices / South Korea / Hyundai Bioland Co., Ltd.
Hyundai Bioland Co., Ltd.: FDA-registered device maker in Cheongju-si Chungbuk, South Korea, 1 510(k) clearance
Hyundai Bioland Co., Ltd. is registered with the FDA (registration 3017847628) in Cheongju-si Chungbuk, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 2, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3017847628
- Address
- 162, Gwahaksaneop 3-ro, Ochang-eup, Cheongwon-gu, Cheongju-si Chungbuk, South Korea, 28125
- Owner or operator
- HYUNDAI BIOLAND Co., Ltd. (10078950)
- Roles
- Manufacturer
- First device listed
- November 11, 2020
- Registered through
- 2026
- Brand names listed
- Oradapt, OssGuide, OsseoSeal, OsteoFlex, T-Gen, TBS Dental, XP-SEAL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Animal Source, Intraoral | NPL | 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 2, 2020 | K200623 | OssGuide | NPL | Substantially Equivalent | Sk Bioland Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 2, 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.