Identity
- Trade Name
- OCS-B FDA UDI
- Generic Name
- Dental bone matrix implant, animal-derived FDA UDI
- Device Name
- The OCS-B OsteoConductive Substitute-Bovine bone grafting material is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The OCS-B contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of OCS-B is effective for the regeneration of new bone around the grafted bone. The OCS-B has good osteoconductivity to enhance new bone formation. The OCS-Bs are supplied as cancellous (spongiosa) or cortical granules in single-use containers. FDA UDI
- Model / Reference
- L1-0210-050 FDA UDI
- Description
- The OCS-B OsteoConductive Substitute-Bovine bone grafting material is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The OCS-B contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of OCS-B is effective for the regeneration of new bone around the grafted bone. The OCS-B has good osteoconductivity to enhance new bone formation. The OCS-Bs are supplied as cancellous (spongiosa) or cortical granules in single-use containers. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809186549080 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 — .5 Gram FDA UDI
Category: Dental bone matrix implant, animal-derived
Ocs-B by Nibec Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 f8fdd297-ed19-451d-85bb-d783c138b281 37 fields · synced May 30, 2026