Identity
- Trade Name
- OsteoFast Dental FDA UDI
- Generic Name
- Bone matrix implant, synthetic, non-antimicrobial FDA UDI
- Model / Reference
- 1.0 ml FDA UDI
Identifiers
- Catalog Number
- USD860010 FDA UDI
- Primary DI / UDI-DI
- 03760177042346 FDA UDI
- FDA Product Code
- LYC FDA UDI
- GMDN Term
- Bone matrix implant, synthetic, non-antimicrobial 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
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: Bone matrix implant, synthetic, non-antimicrobial
OsteoFast Dental is a proprietary, bioabsorbable dental implant device designed to provide osteoconductive bone-tissue scaffolds for filling cystic defects, repairing fractures, and extending autogenous bone grafts. Made from synthetic materials, it offers a non-antimicrobial alternative to traditional implants.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Teknimed
Sources (1)
- FDA UDI 34244486-9215-4cdb-b665-f2a770559167 35 fields · synced Jul 25, 2026