Identity
- Trade Name
- ZCORE FDA UDI
- Generic Name
- Dental bone matrix implant, animal-derived FDA UDI
- Device Name
- Porcine Xenograft Particulate in Syringe, Particle Size 0.25 mm - 1.0 mm, Sterile, Contents: 1.0 cc FDA UDI
- Model / Reference
- ZY100 FDA UDI
- Description
- Porcine Xenograft Particulate in Syringe, Particle Size 0.25 mm - 1.0 mm, Sterile, Contents: 1.0 cc FDA UDI
Identifiers
- Primary DI / UDI-DI
- D765ZY1000 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
- 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 — 1.0 Centiliter FDA UDI
Zcore by Osteogenics Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Osteogenics Biomedical, Inc.
Sources (1)
- FDA UDI d7c7ced9-6791-4f8a-a403-05f75d9990b0 35 fields · synced May 30, 2026