Identity
- Trade Name
- creos xenogain FDA UDI
- Generic Name
- Dental bone matrix implant, animal-derived FDA UDI
- Device Name
- Creos xenogain is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The creos xenogain contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of creos xenogain is effective for the regeneration of new bone around the grafted bone. The creos xenogain has good osteoconductivity to enhance new bone formation. FDA UDI
- Model / Reference
- N1130-B FDA UDI
- Description
- Creos xenogain is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The creos xenogain contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of creos xenogain is effective for the regeneration of new bone around the grafted bone. The creos xenogain has good osteoconductivity to enhance new bone formation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809186540698 FDA UDI
- 510(k) Number
- K113246 FDA UDI
- FDA Product Code
- NPM FDA UDI
- GMDN Term
- Dental bone matrix implant, animal-derived FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 1 Gram FDA UDI
Category: Dental bone matrix implant, animal-derived
creos xenogain by Nibec Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental bone matrix implant, animal-derived.
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Cleared under the same submission
K113246 also covers:
- Instradent XenoGraft — Nibec Co., Ltd.
- Instradent XenoGraft — Nibec Co., Ltd.
- Instradent XenoGraft — Nibec Co., Ltd.
- Instradent XenoGraft — Nibec Co., Ltd.
- Instradent XenoGraft — Nibec Co., Ltd.
- Instradent XenoGraft — Nibec Co., Ltd.
- Instradent XenoGraft — Nibec Co., Ltd.
- Instradent XenoGraft — Nibec Co., Ltd.
- Neodent XenoGraft — Nibec Co., Ltd.
- Neodent XenoGraft — Nibec Co., Ltd.
- Neodent XenoGraft — Nibec Co., Ltd.
- Neodent XenoGraft — Nibec Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nibec Co., Ltd.
Sources (1)
- FDA UDI 03b1d876-f0a2-455f-b720-00f1811c7ac4 37 fields · synced Jun 8, 2026