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ShefaBone SCPC Resorbable Bioactive Bone Graft, is a silica-calcium phosphate composite, synthetic bone graft material for use in oral, dental intraosseous, and maxillofacial bone defects. Typical uses include:

• Periodontal / infrabony defects
• Ridge augmentation (sinusotomy, osteotomy, cystectomy)
• Extraction sites (ridge maintenance/augmentation, implant preparation/ placement)
• Sinus lifts
• Cystic cavities
• Oral and maxillofacial augmentation

ShefaBone SCPC Resorbable Bioactive Bone Graft, is a silica-calcium phosphate composite, synthetic bone graft material. It is resorbable and has a porous structure with a particle size of 90-710 micron. It is processed by thermal treatment to bond the chemical components together. It is packaged in a sealed glass vial containing 1 gm (1cc) of SCPC particles, sealed in an aluminum sterilization pouch, and sterilized by Gama radiation.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a 510(k) premarket notification approval letter for a medical device (ShefaBone SCPC Resorbable Bone Graft) and includes a summary comparing it to a predicate device.

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