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510(k) Data Aggregation

    K Number
    K211551
    Device Name
    Wishbone HA
    Manufacturer
    Wishbone SA
    Date Cleared
    2021-08-20

    (93 days)

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

    Wishbone SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wishbone HA is intended for the following uses: · Filling of infrabony periodontal defects; · Filling of periodontal defects in conjunction with products intended for guided tissue regeneration and guided bone regeneration: · Filling of defects after root resection, apicectomy and cystectomy; - · Filling of extraction sockets to enhance preservation of the alveolar ridge; - · Augmentation or reconstructive treatment of the alveolar ridge; - · Elevation of the maxillary sinus floor; · Filling of peri-implant defects in conjunction with products intended for guided bone regeneration.
    Device Description
    Wishbone HA is a xenograft biomaterial composed of deproteinized hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. Wishbone HA is supplied as a mix of cancellous and cortical particles size 0.25 to 1.0 mm) in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation. The device is intended to be used in medical procedures, by a qualified physician (academically trained dentists, periodontists and oral surgeons).
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