Novabone Dental Putty-Bioactive Synthetic Bone Graft
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100671 FDA 510(k)
- FDA Product Code
- LYC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3930 FDA 510(k)
- Regulation Number
- 872.3930 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The NovaBone Dental Putty Bioactive Synthetic Bone Graft is a synthetic bone grafting material designed to support bone regeneration. Classified as a synthetic bone graft, it promotes osteoconduction and osteostimulation through a bioactive calcium phosphosilicate composition, facilitating new bone formation at the implant site.
This putty-form graft is supplied in sterile, single-use packaging for dental procedures and is regulated under FDA 510(k) clearance and the Medical Devices Directive (MDD). It is intended for use in oral and maxillofacial surgeries, with specific reference codes listed in regulatory databases. The material is fully resorbable and engineered to integrate with natural healing processes.
Frequently asked questions
What types of dental procedures is the NovaBone Dental Putty Bioactive Synthetic Bone Graft intended for?
The NovaBone Dental Putty is designed specifically for oral and maxillofacial surgeries where bone regeneration support is needed. Its bioactive calcium phosphosilicate composition promotes osteoconduction and osteostimulation, making it suitable for procedures like bone grafting around dental implants, ridge augmentation, or sinus lifts—anywhere new bone formation is required to stabilize implants or restore structural integrity.
Is the NovaBone Dental Putty reusable or single-use, and how is it packaged?
The NovaBone Dental Putty is supplied in sterile, single-use packaging, ensuring each unit is uncontaminated for one surgical procedure. This design eliminates the risk of cross-contamination and maintains the material’s integrity for optimal performance in bone regeneration.
How does the resorbable nature of this bone graft affect its clinical use?
The material is fully resorbable, meaning it integrates with the body’s natural healing processes over time. This avoids the need for secondary surgical removal and allows new bone to gradually replace the graft, supporting long-term stability of dental implants or restored bone structure without leaving foreign material in place.
What regulatory pathways has this device undergone, and how does that impact its use?
The NovaBone Dental Putty has undergone FDA 510(k) clearance and complies with the Medical Devices Directive (MDD), confirming its safety and effectiveness for its intended uses. These regulatory pathways ensure the device meets stringent standards for synthetic bone grafts, providing clinicians with confidence in its clinical performance and compliance with global medical device regulations.
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 Dental Putty®, NovaBone® Putty: next-gen synthetic graft - nobelbiocare.com, NovaBone® Dental Putty in Syringe - Osteogenics Biomedical
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K100671 | Class II | Active |
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Manufacturer
- Manufacturer
- NovaBone Products, LLC
Sources (2)
- FDA 510(k) K100671 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026