Identity
- Trade Name
- Neodent XenoGraft FDA UDI
- Generic Name
- Dental bone matrix implant, animal-derived FDA UDI
- Device Name
- The Neodent XenoGraft bone grafting material is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The Neodent XenoGraft contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of Neodent XenoGraft is effective for the regeneration of new bone around the grafted bone. The Neodent XenoGraft has good osteoconductivity to enhance new bone formation. The Neodent XenoGraft are supplied as cancellous (spongiosa) or cortical granules in single-use containers. FDA UDI
- Model / Reference
- I1-0210-200 FDA UDI
- Description
- The Neodent XenoGraft bone grafting material is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The Neodent XenoGraft contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of Neodent XenoGraft is effective for the regeneration of new bone around the grafted bone. The Neodent XenoGraft has good osteoconductivity to enhance new bone formation. The Neodent XenoGraft are supplied as cancellous (spongiosa) or cortical granules in single-use containers. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809186541985 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
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 2.0 Gram FDA UDI
Category: Dental bone matrix implant, animal-derived
Neodent XenoGraft by Nibec Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 6f828a31-1dca-4819-b3c1-0bdff5dfcfd8 37 fields · synced May 30, 2026