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510(k) Data Aggregation

    K Number
    K142040
    Device Name
    OCS-B COLLAGEN
    Manufacturer
    NIBEC CO LTD
    Date Cleared
    2015-07-31

    (368 days)

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

    NIBEC CO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OCS-B Collagen® is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge. - Filling of infrabony periodontal defects. - Filling of defects after root resection, apicoectomy, and cystectomy - 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 (GBR)
    Device Description
    OCS-B Collagen® is a combination of purified cancellous bone mineral granules (OCS-B") and 10% collagen in a block form in a blister and cylinderic form in a syringe and blister. It is sterilized by yirradiation.
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    K Number
    K133507
    Device Name
    GUIDOSS
    Manufacturer
    NIBEC CO LTD
    Date Cleared
    2014-11-05

    (356 days)

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

    NIBEC CO LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GuidOss® is recommended for: - Simultaneous use of membrane (GuidOss®) and implants : 1. - Augmentation around implants placed in immediate extract sockets; 2. - 3. Augmentation around implants placed in delayed extraction sockets; - 4. Localized ridge augmentation for later implantation; - 5. Alveolar ridge reconstruction for prosthetic treatment - 6. Filling of bone defects after root resection, cystectomy, removal of retained teeth. - 7. Guided bone regeneration in dehiscence defects; and - 8. Guided tissue regeneration procedures in periodontal defects.
    Device Description
    GuidOss® is made from pure type I collagen membrane obtained by a standardized controlled manufacturing process. The type I collagen is obtained from veterinary certified porcine and is carefully purified to avoid immunological reactions. GuidOss® membrane is manufactured by fibrillogenesis and crosslinking. The collagen fibers are self-assembled by the process of fibrillogenesis. The crosslinked collagen fibers exhibited increased mechanical strength, thermal stability and increased resistance to pepsin digestion compared to non-crosslinked collagen.
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