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510(k) Data Aggregation

    K Number
    K201546
    Device Name
    OsOpia Synthetic Bone Void Filler
    Manufacturer
    RevisiOs BV
    Date Cleared
    2020-10-02

    (115 days)

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

    RevisiOs BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OsOpia is a bone grafting material indicated for use in the specific treatment of extraction sockets and maxillary sinus augmentation procedures.
    Device Description
    OsOpia is a synthetic, > 90% TCP (Tri-Calcium Phosphate - Ca3(PO4)2) and < 10% Hydroxyapatite (Ca10(PO4)6 (OH)2) resorbable micro-structured bone grafting material for the repair of bony defects. OsOpia induces and guides the three-dimensional regeneration of bone in the defect site into which it is implanted. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all planes (e.g. bioresorbable barrier membranes). When placed next to viable host bone, new bone will be deposited on the surface of the implant resorbs and is replaced by bone during the natural process of bone remodelling. OsOpia is gamma sterilized, comes in several sizes in granular form, and is double sterile packaged for single use only.
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