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510(k) Data Aggregation

    K Number
    K221851
    Device Name
    Lumina-PTFE Titanium
    Manufacturer
    Criteria Industria e Comercio de Produtos Medicinais
    Date Cleared
    2023-12-08

    (529 days)

    Product Code
    NPK
    Regulation Number
    872.3930
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    Applicant Name (Manufacturer) :

    Criteria Industria e Comercio de Produtos Medicinais

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lumina-PTFE Titanium is a temporarily implantable material (non-resorbable) indicated for use as a space-making barrier in the treatment of alveolar and periodontal bony defect sites.
    Device Description
    Lumina-PTFE Titanium is a synthetic, biocompatible, single-use, sterile polymeric barrier composed of a 100% polytetrafluoroethylene (PTFE) reinforced by a titanium structure. The titanium frame is embedded between two layers of PTFE. This medical device is placed between bone grafts and the periosteum in dental bone grafting procedures to stabilize and support the bone graft. The PTFE membrane helps create the space needed for bone-derived cells to repopulate and repair the defect. The PTFE membranes are designed to maintain space and conform to tissue contours. Lumina-PTFE Titanium is provided in thicknesses of 0,25mm and different sizes.
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