# K031073: Perioglas Plus - Settable Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Novabone Products, LLC
- Decided: Nov 5, 2003 after 215 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.
1 later device descends from it; 1 cites it directly.
0 of 10 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.
- K955096: Capset Calcium Sulfate Bone Graft Plaster, Lifecore Biomedical, Inc. (1996) Summary page 1.

## Most influential descendants
- K042707: Grafton Plus DBM Paste (2005), 0 descendants of its own

## Indications for use
PerioGlas Plus - Settable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. PerioGlas Plus is indicated to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and maxillofacial 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); craniofacial augmentation; sinus lifts; cystic defects. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K031073
Methodology: https://510kreport.com/methodology