# K100671: Novabone Dental Putty-Bioactive Synthetic Bone Graft

- Pathway: 510(k) (Special)
- Applicant: Novabone Products, LLC
- Decided: Mar 30, 2010 after 21 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K960978 (1996). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091484: Novabone Dental Putty - Bioactive Synthetic Bone Graft, Novabone Products, LLC (2009) Summary page 1.
- K063549: Novabone Dental Putty-Bioactive Synthetic Bone Graft, Novabone Products, LLC (2007) Summary page 1.

## Indications for use
The intended use of NovaBone Dental Putty is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and craniofacial defects. It is used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (Denmineralized Freeze Dried Bone) or may be mixed with either (typically 1: 1 ratio vlv) as a bone graft extender. Typical uses include: * Periodontal/Infrabony defects * Ridge Augmentation (sinusotomy, osteotomy, cystectomy) * Extraction sites (ridge maintenance/augmentation, implant preparation/placement) * Sinus lifts * Cystic cavities * Cranio-facial augmentation For larger defects, a mixture of NovaBone Dental Putty with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

Source page: https://510kreport.com/device/K100671
Methodology: https://510kreport.com/methodology