Identity
- Trade Name
- NovaBone Dental Putty EUDAMED
- Device Name
- NovaBone Dental Putty EUDAMED
- Model / Reference
- EU0620 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813909010304 EUDAMED
- Basic UDI-DI
- B-00813909010304 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
NovaBone Dental Putty by NovaBone Products, LLC — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-00813909010304 | 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 (1)
- EUDAMED 3ab11021-721f-4d91-8ef5-c46d7469b720 61 fields · synced Jun 9, 2026