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    K Number
    K153230
    Device Name
    ShefaBone SCPC Resorbable Bone Graft
    Manufacturer
    THE IMPLANTECH INC./SHEFABONE
    Date Cleared
    2016-07-14

    (251 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE IMPLANTECH INC./SHEFABONE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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
    Device Description
    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.
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