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Sign in to claim this brandNibec Co., Ltd.
US
Last updated May 24, 2026
What Nibec Co., Ltd. makes
Nibec Co., Ltd. manufactures dental bone matrix implants derived from animal sources, designed to support bone regeneration in oral and maxillofacial procedures. Their portfolio also includes collagen-based dental regeneration membranes, intended for use in guided tissue and bone regeneration applications. Examples include xenograft materials like Straumann Xenograft and Straumann XenoFlex, as well as collagen membranes such as creos xenogain and Regenomer.
The company’s products are classified as Class II medical devices under US regulations and are authorised through the FDA’s 510(k) and Unique Device Identification (UDI) systems. These devices are listed in the FDA’s regulatory databases, ensuring compliance with US medical device requirements. The manufacturer is based in the United States.
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 Nibec Co., Ltd. manufacture?
Nibec Co., Ltd. specializes in the production of dental bone matrix implants derived from animal sources, which are used to support bone regeneration during oral and maxillofacial procedures. Additionally, the company manufactures collagen-based dental regeneration membranes designed for guided tissue and bone regeneration. These products are developed to assist in specific dental surgical applications.
Where is Nibec Co., Ltd. based?
Nibec Co., Ltd. is based in the United States. This location is relevant as the company operates within the US regulatory framework, ensuring that its dental bone matrix implants and collagen membranes meet the specific requirements for medical devices distributed and used within the country.
How are the devices from Nibec Co., Ltd. classified and regulated?
The devices manufactured by Nibec Co., Ltd. are classified as Class II medical devices under US regulations. These products are authorized through the FDA 510(k) process and are tracked via the Unique Device Identification (UDI) system. Their inclusion in these FDA regulatory databases confirms that the individual devices have met the necessary requirements for authorization in the United States.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- nibec.co.kr
- —
- —
- [email protected]
- Phone
- +827050068814
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 687796909
Catalogue (106)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| creos xenogain | N1140 | FDA UDI | Class II | Active |
| Straumann XenoFlex | NI-0110-050 | FDA UDI | Class II | Active |
| Guidoss | K133507 | FDA 510(k) | Class II | Active |
| Regenomer® Syringe, Regenomer® Plug, Regenomer® Block | K150079 | FDA 510(k) | Class II | Active |
| Ocs-B | K113246 | FDA 510(k) | Class II | Active |
| Ocs-B Collagen | K142040 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Nibec Co Ltd Jincheon-gun Chungbuk · KR FEI 3007679154