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Osteo-i Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Osteo-i Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules FDA UDI
- Generic Name
- Dental bone matrix implant, synthetic FDA UDI
- Device Name
- Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. FDA UDI
- Model / Reference
- 04-005-01-SAS FDA UDI
- Description
- Synthetic bone graft substitute in particulate form composed of beta-tricalcium phosphate indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone. FDA UDI
Identifiers
- Catalog Number
- OST404 FDA UDI
- Primary DI / UDI-DI
- 00852108006190 FDA UDI
- FDA Product Code
- LYC FDA UDI
- GMDN Term
- Dental bone matrix implant, synthetic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Commercial Distribution
- Not 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
- Total Volume — 0.5 Milliliter FDA UDI
Osteo-i Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules by Cytophil, Inc — Class II — FDA UDI — listed in FDA GUDID
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
- Cytophil, Inc
Sources (1)
- FDA UDI 66701d27-2170-42ab-b88e-d3fa104f0aae 37 fields · synced Jun 8, 2026