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510(k) Data Aggregation

    K Number
    K242817

    Validate with FDA (Live)

    Device Name
    Jason membrane
    Date Cleared
    2025-12-12

    (450 days)

    Product Code
    Regulation Number
    872.3930
    Panel
    Dental
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Jason membrane alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) is indicated for immediate or delayed guided tissue and bone regeneration.

    • in case of surgical bone defects and bone wall defects
    • in the context of sinus floor augmentation and for support of the Schneiderian membrane
    • in the context of maxillary ridge augmentation
    • in the context of maxillary ridge reconstruction for prosthetic treatment
    • in the context of a treatment of fenestration defects
    • in case of periodontal bone defects (one to three-wall defects, class I and II furcation defects)
    • in case of dehiscence defects
    • after apicoectomy, cystectomy, resection of retained teeth and resection of other bone lesions
    • in extraction sockets after tooth extractions
    • in case of immediate or delayed augmentation around implants in extraction sockets
    Device Description

    Jason® membrane is a completely resorbable collagen membrane used in maxillofacial surgery, implantology, periodontology, oral surgery and endodontology as a barrier membrane to support guided tissue regeneration (GTR) and guided bone regeneration (GBR), for covering implants and for periodontal tissue regeneration. Jason® membrane is produced from porcine pericardium in a standardized, controlled purification process. When dry Jason® membrane is a white collagen matrix with a very dense fiber structure. It possesses sufficient rigidity and stability for a broad variety of intended uses. Jason® membrane possesses a physiological neutral pH-value. Jason® membrane typically resorbs within 12 weeks after implantation. The Jason® membrane is intended to be used in adults only.

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