# K040278: Perioglas-Bioglass Bone Graft Substitute

- Pathway: 510(k) (Special)
- Applicant: Novabone Products, LLC
- Decided: Mar 1, 2004 after 25 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.
80 later devices descend from it; 12 cite it directly.
0 of 89 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)

## Most influential descendants
- K063422: Bioaggregate (2006), 38 descendants of its own
- K080917: Iroot SP (2008), 37 descendants of its own
- K051443: Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio (2005), 18 descendants of its own
- K053387: Perioglas Bone Graft Particulate (2006), 13 descendants of its own
- K082943: Iroot BP, Model Irbp 4609 (2009), 12 descendants of its own

## Indications for use
The intended use of PerioGlas 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/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 PerioGlas® with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

Source page: https://510kreport.com/device/K040278
Methodology: https://510kreport.com/methodology