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NovaBone Dental Putty Cartridge
EUDAMEDClass III (EU MDR)
Ref EU3699Ref EU3620Ref EU4640Ref EU3640
Identity
- Trade Name
- NovaBone Dental Putty Cartridge EUDAMED
- Device Name
- NovaBone Dental Putty Cartridge EUDAMED
- Model / Reference
- EU3699 EUDAMEDEU3620 EUDAMEDEU4640 EUDAMEDEU3640 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813909011301 EUDAMED00813909010366 EUDAMED00813909012100 EUDAMED00813909010380 EUDAMED
- Basic UDI-DI
- B-00813909011301 EUDAMEDB-00813909010366 EUDAMEDB-00813909012100 EUDAMEDB-00813909010380 EUDAMED
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Meet the NovaBone Dental Putty Cartridge, a cutting-edge dental device designed for precise and efficient bone repair. This FDA-cleared product utilizes advanced technology to deliver targeted and sustained release of bioactive molecules, promoting healthy tissue regeneration. With its sterile and implantable design, it's an ideal solution for various clinical applications.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00813909011301 | Class III | Active |
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Manufacturer
- Manufacturer
- NovaBone Products, LLC
- EUDAMED SRN
- US-MF-000020624
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 28b96a5b-978e-4fc7-b972-efa96f7cf263 61 fields · synced Jul 29, 2026
- EUDAMED 3d4c6240-fba8-4bc0-9eaa-5e946fb79baa 61 fields · synced May 16, 2026
- EUDAMED 34696866-9a2d-410a-b57b-3a6f2c414526 61 fields · synced May 17, 2026
- EUDAMED 3c1c86eb-ada0-4842-8082-2d460cc023b3 61 fields · synced May 18, 2026