# K033994: Novabone-BBG-Resorbable Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Novabone Products, LLC
- Decided: Mar 25, 2004 after 92 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: 2 generations back to K941780 (1995). 8 ancestors in all.
85 later devices descend from it; 1 cites it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K000149: Novabone-Bioglass Bone Graft Particulate, Usbiomaterials Corp. (2000)
- K952922: Biogran Bioactive Glass Synthetic Bone Graft Material, Orthovita Co. (1995) Summary page 1.

## Most influential descendants
- K041613: Novabone - AR - Resorbable Bone Graft Substitute (2004), 84 descendants of its own
- K082672: Novabone Putty-Bioactive Synthetic Bone Graft (2008), 59 descendants of its own
- K101860: Novabone Putty- Bioactive Synthetic Bone Graft (2010), 47 descendants of its own
- K110368: Novabone Putty - Bioactive Synthetic Bone Graft (2011), 43 descendants of its own
- K112773: Novabne Putty Bioactive Synthetic Bone Graft (2011), 38 descendants of its own

## Indications for use
NovaBone-BBG - Resorbable Bone Graft Substitute is indicated to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/ maxillo-facial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including: periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. NovaBone-BBG may be used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender. NovaBone-BBG is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.

Source page: https://510kreport.com/device/K033994
Methodology: https://510kreport.com/methodology