Manufacturer registered with FDA
HYUNDAI BIOLAND Co., Ltd.
Cheongju-si, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 7
- 510(k) clearances
- 12026–2026
- Markets registered in
- 89 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name HYUNDAI BIOLAND Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | HYUNDAI BIOLAND Co., Ltd. | 1 clearances | 2026–2026 | Below |
| Taiwan | TFDA | Manufacturer | HYUNDAI BIOLAND Co., Ltd. | 3 | 2016–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | HYUNDAI BIOLAND Co Ltd | 1 | 2023–2023 | Pure Global AI |
| China | NMPA | Registration holder | （株）现代百朗德HYUNDAI BIOLAND CO., Ltd. | 1 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | HYUNDAI BIOLAND Co. Ltd., | 1 | 2022–2022 | Pure Global AI |
| Israel | AMAR | Manufacturer | Hyundai Bioland Co.,Ltd. | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | HYUNDAI BIOLAND CO., LTD. | 1 | 2025–2025 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | HYUNDAI BIOLAND Co., Ltd. | 1 | 2024–2024 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What HYUNDAI BIOLAND Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | OradaptOsseoSealOssGuideOsteoFlexT-GenTBS DentalXP-SEAL | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
HYUNDAI BIOLAND Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Sk Bioland Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Oct 2020 | K200623 | OssGuide | Sk Bioland Co., Ltd. | NPL Intraoral Animal Source Barrier |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HYUNDAI BIOLAND CO., LTD.FDA reg. 3017847628 | Cheongju-si Chungbuk, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10078950). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.