Identity
- Trade Name
- 3D Bond FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- A synthetic, osteoconductive, bioresorbable graft binder cement composed of Biphasic Calcium Sulfate in a granulated powder form. 3D Bond functions as a scaffold for bone regeneration in dental procedures, and is intended to fill, augment, or reconstruct bony defects in the oral and maxillofacial region. FDA UDI
- Model / Reference
- DD2-050 FDA UDI
- Description
- A synthetic, osteoconductive, bioresorbable graft binder cement composed of Biphasic Calcium Sulfate in a granulated powder form. 3D Bond functions as a scaffold for bone regeneration in dental procedures, and is intended to fill, augment, or reconstruct bony defects in the oral and maxillofacial region. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290014838000 FDA UDI
- 510(k) Number
- K083858 FDA UDI
- FDA Product Code
- LYC FDA UDI
- GMDN Term
- Synthetic bone graft 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
Yes
FDA UDI
3D Bond by Augma Biomaterials, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K083858 also covers:
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
- Augma Biomaterials, Ltd.
Sources (1)
- FDA UDI a9adeb38-f97b-49a3-95b7-a3a160b34a21 36 fields · synced May 30, 2026