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510(k) Data Aggregation

    K Number
    K200623
    Device Name
    OssGuide
    Date Cleared
    2020-10-02

    (207 days)

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

    Sk bioland Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OssGuide is recommended for: - Simultaneous use of GBR-membrane (OssGuide) and implants; - Augmentation around implants placed in immediate extraction sockets; - Augmentation around implants placed in delayed extraction sockets; - Localized ridge augmentation for later implantation; - Alveolar ridge reconstruction for prosthetic treatment; - Aid regeneration of bone defects after root resection, cystectomy, removal of retained teeth; - Guided bone regeneration in dehiscence defects
    Device Description
    OssGuide (Absorbable collagen membrane) is made of purified collagen without further cross-linking or chemical treatment. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. The OssGuide is a collagen membrane obtained by a standardized controlled manufacturing process. The OssGuide has a porous and fibrous microstructure that prevents the ingrowth of fibrous tissue into the bone defect. OssGuide functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled, resorbed, and replaced by host tissue. OssGuide is substantially resorbed within 24 weeks after implantation.
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