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510(k) Data Aggregation

    K Number
    K141177
    Device Name
    VITALA PORCINE DERIVED COLLAGEN MEMBRANE
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC. (FORMERLY OBI BIOLOGI
    Date Cleared
    2015-09-15

    (496 days)

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

    OSTEOGENICS BIOMEDICAL, INC. (FORMERLY OBI BIOLOGI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vitala® Porcine Derived 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® Porcine Derived Collagen Membrane is a natural collagen membrane for use in periodontal and/or dental surgical procedures. The membrane is manufactured using a standardized, controlled, multistage process. The pre-slaughter origin of all animals is the United States of America and the source collagen is extracted from veterinary-certified pigs sacrificed in a USDA-inspected facility. The membrane is terminally sterilized in double blister packs by electron beam irradiation. The contents of the unopened, undamaged inner package are sterile. Vitala® Porcine Derived Collagen Membrane functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled and replaced by host tissue. Animal studies have shown that Vitala® Porcine Derived Collagen Membrane is substantially resorbed by 26 weeks.
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