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510(k) Data Aggregation

    K Number
    K103820
    Device Name
    REPROBONE DENTAL GRAFTING MATERIAL
    Manufacturer
    Date Cleared
    2011-11-03

    (308 days)

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

    CERAMISYS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ReproBone is recommended for augmentation or reconstructive treatment of the alveolar ridge. Filling of infrabony periodontal defects. Filling of defects after root resection apicoectomy and cystectomy. Filling of extraction sockets to enhance preservation of the alveolar ridge. Elevation of the maxillary sinus floor. Filling of periodontal defects in conjunction with products intended for guided tissue regeneration (GTR) and guided bone regeneration (GBR). Filling of peri-implant defects in conjunction with products intended for guided bone regeneration (GBR).
    Device Description
    ReproBone® is a sterile, single-use, resorbable bone void filler. ReproBone® is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate. ReproBone" has a highly interconnected, highly porous structure, similar to that of human cancellous bone, and is available in the form of granules of size range 0.5 - 1.0mm, and also 0.8-1.5mm. Following placement in the bony voids or gap, ReproBone® acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. ReproBone® gradually resorbs and is replaced with bone during the healing process
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    K Number
    K110554
    Device Name
    BIOCERAMIC ORBITAL IMPLANT, ORBTEX
    Manufacturer
    Date Cleared
    2011-11-02

    (247 days)

    Product Code
    Regulation Number
    886.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    CERAMISYS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ceramisys synthetic orbital implants of either hydroxyapatite or alumina oxide (alumina) are indicated for orbital implantation at the time of enucleation or evisceration of the natural eyeball. They may also be indicated for secondary implantation where extrusion, migration or other malfunction of the primary orbital implant has occurred.
    Device Description
    Not Found
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