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510(k) Data Aggregation

    K Number
    K140021
    Device Name
    TI-OSS
    Manufacturer
    Date Cleared
    2015-06-05

    (518 days)

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

    CHIYEWON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ti-oss® is intended for use in dental surgery. The product is recommended for the following surgeries : * Augmentation or reconstructive treatment of alveolar ridge * Filling of periodontal defects * Filling of defects after root resection, apicoectorny, and cystectorny * Filling of extraction sockets to enhance preservation of the alveolar ridge * Elevation of 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 Guided Bone Regeneration
    Device Description
    Ti-oss is a sterile, porous bone mineral matrix produced by the removal of organic compounds from bovine bone. It is supplied as cancellous (spongiosa) or cortical granules in a single use container, packaged in a secondary thermoform blister, and sterilized by yirradiation.
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