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OSSAPLAST DENTAL is intended for use in filling, augmenting, or reconstructing periodontal or bony defects of the oro-maxillofacial region. It is recommended for:

• Augmentation or reconstructive treatment of the alveolar ridge.
• Filling of periodontal defects.
• Filling of defects after root resection, apicoectomy, and cystectomy.
• Filling of extraction sockets to enhance preservation of the alveolar ridge.
• Elevation of the maxillary sinus floor.
• Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
• Filling of peri-implant defects in conjunction with products intended for GBR.

OSSAPLAST DENTAL is a synthetic, implantable, resorbable, radiopaque βtricalcium phosphate (β-ΤCP) ceramic in granulate form. It consists of purephase β-ΤCP [Саз(РОд)½] and is csteoconductive, with high interconnecting porosity. OSSAPLAST DENTAL is supplied sterile in sealed glass vials, in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, or adjudication methods. The document is a 510(k) summary for a "Bone Grafting Material" called OSSAPLAST DENTAL, primarily focusing on its substantial equivalence to predicate devices and its intended use. It describes the device's material, form, packaging, sterility, and biocompatibility, but it does not present data from any clinical or performance studies that would typically include acceptance criteria and study results. Therefore, I cannot fulfill your request based on the given input.

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