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NovaBone Dental Putty
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref EU0610510(k) K063549
Identity
- Trade Name
- NovaBone Dental Putty EUDAMED
- Device Name
- NovaBone Dental Putty EUDAMED
- Model / Reference
- EU0610 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813909010298 EUDAMED
- Basic UDI-DI
- B-00813909010298 EUDAMED
- 510(k) Number
- K063549 FDA 510(k)
- FDA Product Code
- LYC FDA 510(k)
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3930 FDA 510(k)
- Regulation Number
- 872.3930 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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 — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063549 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-00813909010298 | 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 (2)
- EUDAMED db258678-0e8b-4399-b7be-a50a16c7db4c 61 fields · synced Jun 20, 2026
- FDA 510(k) K063549 24 fields · synced May 18, 2026