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510(k) Data Aggregation

    K Number
    K091424
    Device Name
    OSTA MAXIGRO AND REGIGRO
    Manufacturer
    Date Cleared
    2010-08-18

    (462 days)

    Product Code
    Regulation Number
    872.3930
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    Applicant Name (Manufacturer) :

    OSTA TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Osta Maxigro™ in both forms (powder & blocks) and Osta Regigro™ in both forms (powder & blocks) are Recommended for: Filling of large oral and maxillofacial intra-osseous cavities. 1. Augmentation or reconstructive treatment of alveolar ridge 2. Filling of periodontal defects 3. Filling of defects after root resection, apicectomy, and cystectomy 4. Filling of extraction sockets to enhance preservation of the alveolar ridge 5. Elevation of maxillary sinus floor 6. Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
    Device Description
    Osta Maxigro™ and Osta Regigro™ are natural bone minerals which have been derived from a bovine extract. The material is essentially free from collagen and comprises of a highly purified mineral structure with micropores and trabecules which is comparable to that of human bone. The materials are prepared by extracting the fat and removal of the collagen, thereby resulting in a pure bone mineral that is sintered in block form and then crushed to form powder granules. This natural sponge like geometry comprising of Hydroxyapatite nano-crystalls results in a high internal surface area scaffold that typically exceeds 100m /g for Osta Maxigro™ and 80m /g for Osta Regigro™. The high surface area properties of these materials make them ideal for allowing blood flow to the wound site where bony contact is established during the bone remodeling process. Osta Maxigro™ and Osta Regigro™ have low crystallinities comparable to that of human bone which is completely resorbed and replaced by host bone during bone regeneration process. The materials support bone formation but do not induce bone formation. Osta Maxigro™ are available in powder or block form and both undergo final sterilization by y- radiation of Osta Maxigro™ blocks and granules can be utilized for the indications shown below depending on the defect size. Osta Maxigro™ Blocks is ideally recommended for filling of large bone cavities with limited bone height and or wall thickness.
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