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510(k) Data Aggregation

    K Number
    K972278
    Device Name
    CYTOPLAST REGENTEX TITANIUM 250
    Manufacturer
    OSTEOGENICS CO.
    Date Cleared
    1997-08-06

    (49 days)

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

    OSTEOGENICS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects. A temporarily implantable material (non-resorbable) for use as a spacemaking barrier in the treatment of periodontal bone defects.
    Device Description
    The Cytoplast™ Regentex Titanium 250 Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film reinforced with a titanium framework. The membrane has a nominal thickness of 250 microns. Membranes are supplied sterile in sealed pouches in a variety of shapes and sizes. The biocompatibility of polytetrafluoroethylene (PTFE) and titanium has been established through a long history of use in a variety of implant devices. No additional biocompatibility testing has been conducted with this device.
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    K Number
    K964342
    Device Name
    CYTOPLAST GBR
    Manufacturer
    OSTEOGENICS CO.
    Date Cleared
    1997-03-11

    (131 days)

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

    OSTEOGENICS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
    Device Description
    The Cytoplast™ GBR Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film with a nominal thickness of 250 microns and supplied in a variety of shapes and sizes. Membranes are supplied sterile in sealed pouches. The biocompatibility of polytetrafluoroethylene (PTFE) has been established through a long history of use in a variety of long-term PTFE implant devices, such as PTFE vascular prostheses and cardiovascular patches. The Cytoplast™ GBR Non-Absorbable Barrier Membrane has been shown to be non-cytotoxic.
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