Identity
- Trade Name
- Bond Apatite FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- Bond Apatite EUDAMEDA synthetic, osteoconductive, composite graft cement composed of Biphasic Calcium Sulfate and Hydroxyapatite granules. Bond Apatite 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
- HA-BB-PACK1 EUDAMEDFDA UDI
- Description
- A synthetic, osteoconductive, composite graft cement composed of Biphasic Calcium Sulfate and Hydroxyapatite granules. Bond Apatite 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
- 07290014838024 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290014838024 EUDAMED
- FDA Product Code
- LYC FDA UDI
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES EUDAMED
- GMDN Term
- Synthetic bone graft FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Bond Apatite by Augma Biomaterials — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07290014838024 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Augma Biomaterials
- EUDAMED SRN
- IL-MF-000020802
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 876c4da3-426e-4577-8fb2-389e7cfcedcf 61 fields · synced Jun 18, 2026
- FDA UDI 3cc732ee-9a49-4285-bc95-54bff365bcd3 35 fields · synced May 30, 2026