NovaBone Putty - Bioactive Synthetic Graft
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K080009 FDA 510(k)
- FDA Product Code
- MQV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3045 FDA 510(k)
- Regulation Number
- 888.3045 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The NovaBone Putty - Bioactive Synthetic Graft is a synthetic bone graft substitute classified as a bone graft substitute (FDA Product Code: MQV). It is composed of bioactive calcium phosphosilicate (CPS) particles designed to support bone regeneration through osteoconductive and osteostimulative properties. The material is fully resorbable, integrating with natural bone tissue while promoting controlled ion release of silicon (Si), calcium (Ca), and phosphorus (P). This facilitates new bone formation at the graft site, making it suitable for orthopedic and dental applications requiring structural support during healing.
This putty is supplied in a ready-to-use form, requiring no additional preparation before application. It is intended for single-use only and must be handled aseptically to maintain sterility. The device is regulated under FDA 510(k) clearance (K080009), classified as substantially equivalent to predicate devices in the orthopedic category. Storage instructions specify protection from moisture and extreme temperatures, ensuring stability until use. No MRI safety information is provided in the regulatory submission.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Reforming Patients Futures - NovaBone, NovaBone® Putty: next-gen synthetic graft - nobelbiocare.com, NovaBone® Dental Putty in Cartridges - Osteogenics, NovaBone Putty - NovaBone
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080009 | Class II | Active |
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Manufacturer
- Manufacturer
- NovaBone Products, LLC
Sources (1)
- FDA 510(k) K080009 24 fields · synced Oct 5, 2026