# K112428: Novabone Dental Morsels - Bioactive Synthetic Bone Graft

- Pathway: 510(k) (Traditional)
- Applicant: Novabone Products, LLC
- Decided: Dec 16, 2011 after 115 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). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 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) Summary page 1.
- K930115: Perioglass, Usbiomaterials Corp. (1993) Summary page 1.
- K060432: Novabone Porous-Bone Graft Scaffold, Novabone Products, LLC (2006) Summary page 1.
- K090731: Novabone Porous - Synthetic Bone Graft Scaffold, Novabone Products, LLC (2009) Summary page 1.

## Indications for use
The intended use of NovaBone Dental Morsels is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and maxillofacial bone defects. It is used in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone). Typical uses include: * Periodontal / infrabony defects * Ridge augmentation (sinusotomy, osteotomy, cystectomy) * Extraction sites (ridge maintenance/augmentation, implant preparation/placement) * Sinus lifts * Cystic cavities * Oral and maxillofacial augmentation

Source page: https://510kreport.com/device/K112428
Methodology: https://510kreport.com/methodology