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3D Bond+
EUDAMEDFDA UDIClass III (EU MDR)
Ref 3D-ND-LMMRef 3D-ND-050Ref DD-100-LMM
Identity
- Trade Name
- 3D Bond+ EUDAMED3D Bond EUDAMEDFDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- 3D Bond+ EUDAMED3D Bond EUDAMED
- Model / Reference
- 3D-ND-LMM EUDAMED3D-ND-050 EUDAMEDDD-100-LMM EUDAMEDDD-100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290014838147 EUDAMED07290014838048 EUDAMED17290014838205 EUDAMED07290014838062 FDA UDI
- Basic UDI-DI
- B-07290014838147 EUDAMEDB-07290014838048 EUDAMEDB-17290014838205 EUDAMED
- 510(k) Number
- K083858 FDA UDI
- 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
- Hungary EUDAMEDFrance EUDAMED
- Commercial Distribution
- 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
No
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 — 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-07290014838147 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Augma Biomaterials Ltd.
- EUDAMED SRN
- IL-MF-000020802
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (4)
- EUDAMED 0123a053-3ff1-4acd-8c60-6b227d6817af 61 fields · synced Jul 20, 2026
- EUDAMED f90504f0-54b6-408d-9dc9-94bddeb99887 61 fields · synced May 18, 2026
- FDA UDI b446041d-f22a-4341-b14d-731ba15d8967 33 fields · synced May 30, 2026
- EUDAMED e643c159-20a3-41ab-aff7-0934a5771992 61 fields · synced Jul 17, 2026