# K992416: Perioglas- Bioglass Bone Graft Particulate

- Pathway: 510(k) (Traditional)
- Applicant: Usbiomaterials Corp.
- Decided: Oct 15, 1999 after 87 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: 1 generation back to K852682 (1985). 2 ancestors in all.
189 later devices descend from it; 10 cite it directly.
0 of 192 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852682: Calcitite Bone Graft Mat/Oral & Maxillofacial Surg, Calcitek, Inc. (1985) Summary page 1.
- K970321: Bio-Oss Anorganic Bovine Bone, Geistlich-Pharma (1998) Summary page 1.

## Most influential descendants
- K033994: Novabone-BBG-Resorbable Bone Graft Substitute (2004), 85 descendants of its own
- K041613: Novabone - AR - Resorbable Bone Graft Substitute (2004), 84 descendants of its own
- K040278: Perioglas-Bioglass Bone Graft Substitute (2004), 80 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

## Indications for use
The intended use of PerioGlas is to provide a safe, biocompatible synthetic bone graft material for oral/maxillofacial and dental intraosseous defects use. It is to be used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (DFDBA demineralized freeze dried bone) or may be mixed with each as a bone graft extender. Typical uses incluge: Periodontal/Infrabony defects Ridge augmentation Extraction sites Cranio-facial augmentation Cystic cavities Sinus lifts

Source page: https://510kreport.com/device/K992416
Methodology: https://510kreport.com/methodology