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Sign in to claim this brandWhat HYUNDAI BIOLAND Co., Ltd. makes
Hyundai Bioland produces collagen-based dental regeneration membranes and sealants, including barrier membranes for guided bone regeneration (e.g., OssGuide) and collagen-based sealants for dental applications (e.g., Oradapt, OsseoSeal). Their portfolio also includes dental adhesives (e.g., XP-Seal) and regenerative materials for tissue integration in oral surgery procedures.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to U.S. medical device compliance requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Hyundai Bioland Co., Ltd. manufacture?
Hyundai Bioland Co., Ltd. specializes in collagen-based dental devices. Their primary focus is on dental regeneration membranes, such as barrier membranes for guided bone regeneration (e.g., OssGuide), as well as collagen sealants (e.g., Oradapt, OsseoSeal) and dental adhesives (e.g., XP-Seal). These products are designed for oral surgery and tissue integration applications.
Where is Hyundai Bioland Co., Ltd. based, and what regulatory framework does it follow?
Hyundai Bioland Co., Ltd. is based in the United States. Since their devices are marketed there, they must comply with U.S. medical device regulations, including classification and listing requirements under the FDA. Their products are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting adherence to U.S. regulatory standards.
How are Hyundai Bioland’s devices classified under FDA regulations?
Hyundai Bioland’s devices are classified as Class II under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as collagen-based dental regeneration membranes and sealants.
Which regulatory registries or databases list Hyundai Bioland’s medical devices?
Hyundai Bioland’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and regulatory compliance for authorized products.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 688235061
Catalogue (22)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OssGuide | TG-4 | FDA UDI | Class II | Active |
| OssGuide | TG-2 | FDA UDI | Class II | Active |
| T-Gen | TG-4 | FDA UDI | Class II | Active |
| Oradapt | OA3040 | FDA UDI | Class II | Active |
| XP-Seal | XP-3 | FDA UDI | Class II | Active |
| T-Gen | TG-3 | FDA UDI | Class II | Active |
| TBS Dental | TBSRGN05 | FDA UDI | Class II | Active |
| OssGuide | TG-3 | FDA UDI | Class II | Active |
| T-Gen | TG-1 | FDA UDI | Class II | Active |
| OssGuide | TG-5 | FDA UDI | Class II | Active |
| Oradapt | OA2030 | FDA UDI | Class II | Active |
| OsseoSeal | OS3040 | FDA UDI | Class II | Active |
| TBS Dental | TBSRGN07 | FDA UDI | Class II | Active |
| TBS Dental | TBSRGN06 | FDA UDI | Class II | Active |
| T-Gen | TG-2 | FDA UDI | Class II | Active |
| Oradapt | OA1520 | FDA UDI | Class II | Active |
| XP-Seal | XP-2 | FDA UDI | Class II | Active |
| OsseoSeal | OS2030 | FDA UDI | Class II | Active |
| OsseoSeal | OS1520 | FDA UDI | Class II | Active |
| OssGuide | TG-1 | FDA UDI | Class II | Active |
| XP-Seal | XP-1 | FDA UDI | Class II | Active |
| T-Gen | TG-5 | FDA UDI | Class II | Active |
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