# K063549: Novabone Dental Putty-Bioactive Synthetic Bone Graft

- Pathway: 510(k) (Traditional)
- Applicant: Novabone Products, LLC
- Decided: Feb 12, 2007 after 80 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: 5 generations back to K960978 (1996). 20 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053387: Perioglas Bone Graft Particulate, Novabone Products, LLC (2006) Summary page 1.
- K040278: Perioglas-Bioglass Bone Graft Substitute, Novabone Products, LLC (2004) Summary page 1.
- K992416: Perioglas- Bioglass Bone Graft Particulate, Usbiomaterials Corp. (1999) Summary page 1.
- K962494: Perioglas - Bioglass Bone Graft Particulate, Usbiomaterials Corp. (1996). Our reading of the summary gave K962492, FDA’s number for Silenzio Plus Continuous Positive Airway Pressure System (Nidek Medical Products, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “PerioGlas - Synthetic Bone Graft Particulate”.
- K930115: Perioglass, Usbiomaterials Corp. (1993) Summary page 1.
- K060728: Novabone Putty - Bioactive Synthetic Graft, Novabone Products, LLC (2006) Summary page 1.
- K020078: Exactech Resorbable Bone Paste, Exactech, Inc. (2004) Summary page 1.
- K051195: Grafton DBM, Osteotech, Inc. (2005) Summary page 1.

## Most influential descendants
- K091484: Novabone Dental Putty - Bioactive Synthetic Bone Graft (2009), 1 descendant of its own
- K100671: Novabone Dental Putty-Bioactive Synthetic Bone Graft (2010), 0 descendants of its own

## 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 (Demineralized Freeze Dried Bone) or may be mixed with either (typically 1:1 ratio v/v) as a bone graft extender. Typical uses include: * Periodontal/lnfrabony 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/K063549
Methodology: https://510kreport.com/methodology