FG Bone Graft B

FG Bone Graft B is a sterile, synthetic, multi-porous ceramic matrix made of beta-tricalcium phosphate in granular form. It is used to fill bone defects in dental and oral surgery applications, including alveolar ridge augmentation, periodontal defect filling, extraction socket preservation, sinus floor elevation, and guided bone regeneration procedures.

FG Bone Graft B has a microporous structure with ≥99% phase purity of beta-TCP, particle size of 500–1000 μm, Ca/P ratio of 1.89–1.95, volumetric porosity of 68.3%, and pH ~7.9 over 7 days. It is sterilized by gamma irradiation to a sterility assurance level of 10⁻⁶ and contains polyethylene and sucrose as additional components, matching the predicate device composition and properties.

ASTM F 1088-04 for ceramic material specification; ISO 10993 series for biocompatibility testing (cytotoxicity, intracutaneous reactivity, skin sensitization, pyrogen, acute and repeat-dose systemic toxicity, bone implant, and genotoxicity); USP 151 for pyrogen testing; and Masson-Goldner staining for histological analysis.

FG Bone Graft B is substantially equivalent to CERASORB M DENTAL (K051443) because both devices are beta-TCP bone void fillers with identical regulatory classification, intended uses, material composition, sterilization method, and performance specifications. In vivo animal testing demonstrated that FG Bone Graft B achieves comparable new bone formation rates, material degradation kinetics (~90% degraded by 12 weeks), and minimal inflammatory response as the predicate, with physical and chemical properties meeting Special Controls Guidance requirements.