BONTREE PLUS

BONTREE PLUS is a synthetic bone graft substitute composed of hydroxyapatite (HA) and octacalcium phosphate (OCP) supplied as sterile granules in vials. It is intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects, including periodontal/infrabony defects, ridge augmentation, extraction sites, sinus lifts, and cystic cavities.

BONTREE PLUS contains 30 wt% HA and 70 wt% OCP with a porosity of ≥40%, pore size ≥0.1 µm, particle size range of 0.3–1.4 mm, Ca/P ratio of 1.4 ± 0.1, and ≥60% crystallinity. The predicate OSTEON II contains 25–45 wt% HA and 55–75 wt% β-TCP with 70% porosity and 250 µm macropore size. Key difference: BONTREE PLUS uses OCP instead of β-TCP, though both are well-established resorbable calcium phosphates with similar osteoconductive functions.

ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation, pyrogenicity, acute/subchronic toxicity, hemolysis, genotoxicity, implantation); ISO 11137 and ISO 11137-2 (sterilization validation); ISO 2591-1 (particle characterization); ASTM F88, F1929, F1886 (packaging integrity); ISO 13175-3 (compression testing); USP and Korean Pharmacopoeia methods for extraction pH, endotoxin, and heavy metals.

BONTREE PLUS is substantially equivalent to OSTEON II because both are synthetic calcium phosphate bone graft materials with identical indications for use, same regulatory classification (Class II), and same product code (LYC). Although BONTREE PLUS uses OCP instead of β-TCP and has different porosity and pore size specifications, both components are well-established resorbable calcium phosphates with comparable osteoconductive function. Biocompatibility testing and preclinical animal studies in a canine mandibular defect model demonstrated equivalent bone regeneration, minimal inflammatory response, and no new safety concerns compared to the predicate.