Synthetic Bone Graft Particulate

Synthetic Bone Graft Particulate is a synthetic absorbable bone graft substitute made from 45S5 bioactive glass in particulate form (0.5–1 mm particles). It is mixed with sterile saline to form a paste and packed into tooth extraction sockets to augment alveolar bone; the material is progressively resorbed and replaced by new bone tissue during healing.

Both the proposed device and predicate (PerioGlas) are calcium phospho-silicate bioactive glass materials in irregular dense particulate morphology designed as non-structural scaffolds. The proposed device has a particle size of 500–1000 microns compared to the predicate's 90–710 microns, but both exhibit similar bioactivity, resorption kinetics (majority absorbed by six months), and osteoconductive bone infiltration mechanisms.

ISO 11137 (sterilization), ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation, implantation, genotoxicity), USP <151> and ISO 10993-11 (pyrogenicity), ASTM F1538-03 (chemical composition and crystallinity), ISO 9276-6 (morphology), USP <786> (particle size distribution), USP <791> (pH), ISO 23317 (bioactivity), OECD Test No. 105 (water solubility), and USP <85> (bacterial endotoxin).

Both devices share identical material composition (bioactive glass), same intended use (alveolar bone augmentation in extraction sockets), and equivalent application method (gentle packing as non-structural scaffold). Although the proposed device's particle size range (500–1000 µm) is slightly narrower than the predicate's (90–710 µm), both fall within overlapping ranges and demonstrate comparable bioactivity and resorption profiles. A canine dental defect model study comparing the proposed and predicate devices showed equivalent in vivo absorbability and bone healing/regeneration at 4, 12, and 26 weeks post-operation.