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510(k) Data Aggregation

    K Number
    K102531
    Device Name
    MUCOGRAFT
    Manufacturer
    ED. GEISTLICH SOEHNE AG FUR CHEMISCHE INDUSTRIE
    Date Cleared
    2010-11-17

    (75 days)

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

    ED. GEISTLICH SOEHNE AG FUR CHEMISCHE INDUSTRIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - covering of implants placed in immediate or delayed extraction sockets; - localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants; - alveolar ridge reconstruction for prosthetic treatment; - guided tissue regeneration procedures in recession defects for root coverage
    Device Description
    MUCOGRAFT® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. MUCOGRAFT® is sterilized in double blisters by gamma irradiation. MUCOGRAFT® has a bilayer structure with one smooth, non-permeable layer and one porous. The "outer," smooth side has a smooth surface which is cell occlusive and prevents cell adhesion and acts as a barrier. It allows tissue adherence favoring wound healing. This side is turned towards the soft tissue. The smooth texture has appropriate elastic properties to accommodate i suturing to the host mucosal margins and to protect the graft material from oral trauma during biode radation and healing. The "inner" porous layer consists of collagen fibers in a loose, porous arrangement to enable cell invasion. This porous layer is made from pig skin. This side is turned toward the bone defect and/or soft tissue to encourage boneforming cells and tissue growth and to stabilize the blood clot.
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    K Number
    K090401
    Device Name
    ORTHOSS
    Manufacturer
    ED. GEISTLICH SOEHNE AG FUR CHEMISCHE INDUSTRIE
    Date Cleared
    2010-01-08

    (325 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    ED. GEISTLICH SOEHNE AG FUR CHEMISCHE INDUSTRIE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ORTHOSS® Resorbable Bone Void Filler is indicated for bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). ORTHOSS® is indicated only for use in bone voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ORTHOSS® Resorbable Bone Void Filler is intended to be used in the spine only for posterolateral fusion.
    Device Description
    ORTHOSS® is a natural non-antigenic, porous bone mineral. It is produced by removal of all organic components from bovine bone. Due to its natural structure, it is physically and chemically comparable to the mineralized matrix of human bone.
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