Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K101426
    Device Name
    CEROS TCP GRANULES
    Manufacturer
    MATHYS LTD
    Date Cleared
    2010-09-15

    (117 days)

    Product Code
    LYC
    Regulation Number
    872.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    MATHYS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ceros® TCP Granules are indicated for use as a bone void filler in non-loadbearing areas in the oral and maxillofacial regions requiring cancellous rather than cortical bone material. Ceros TCP Granules may, for example, be used for: - · supplementing autogenous cancellous bone - · supporting and stabilizing for guided bone regeneration, "GBR" - · filling bone cavities after hemisection of teeth, bone removal, osteotomy, tumor resection, root apex resection, tooth extraction or cystectomy - · filling bone defects resulting from traumatic or pathological origin - · augmenting an atrophied mandibular ridge (only in conjunction with the "GBR" membrane technique) - · filling defects after explantation of dental implants - · filling small periodontal bone cavities as well as bi- and tri-furcations of teeth - · the reconstruction of alveolar defects prior to providing a prosthesis - · preparation of the implant bed (e.g. sinus lift) - · filling bone defects around dental implant after immediate placement into extraction sockets Ceros® TCP Granules are intended to be gently packed or placed into the surgical site and may be combined with autogenous blood, bone marrow or saline.
    Device Description
    Ceros® TCP Granules are a synthetic, porous, osteoconductive, bioresorbable bone grafting material composed of beta-tricalcium phosphate, ß-TCP, [ß-C23]PO4]2] intended to fill, augment, or reconstruct bony defects in dental, oral or maxillofacial surgery. Ceros® TCP Granules are provided in volumes of 0.5, 1.0 and 2.5 g.
    Ask a Question

    Page 1 of 1