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510(k) Data Aggregation

    K Number
    K101453
    Device Name
    VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE
    Manufacturer
    OBI BIOLOGICS, INC.
    Date Cleared
    2011-07-21

    (422 days)

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

    OBI BIOLOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vitala™ Resorbable Natural Collagen Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for: - Simultaneous use with 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; - Alveolar ridge preservation consequent to tooth extraction; - Filling of bone defects after root resection, cystectomy, removal of retained teeth; - Over the window in lateral window sinus elevation procedures; - Furcation defects in multi-rooted teeth; - Treatment of recession defects, together with coronally positioned flap; - In implants with vertical bone loss due to infection, only with satisfactory debridement and implant surface disinfection; - Guided bone regeneration in dehiscence defects; and - Guided tissue regeneration in periodontal defects.
    Device Description
    Vitala™ Resorbable Natural Collagen Membrane is a natural collagen membrane sourced from veterinary certified pigs. Vitala™ Resorbable Natural Collagen Membrane, minimally manipulated without further cross-linking, is sterilized in a double tray package configuration via E-beam irradiation.
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