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510(k) Data Aggregation

    K Number
    K033110
    Device Name
    C-GRAFT
    Date Cleared
    2003-12-10

    (71 days)

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

    THE CLINICIAN'S PREFERENCE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    C-GRAFT™ is indicated for: - Augmentation of bony defects of the alveolar ridge - Sinus elevation grafting - Treatment of intrabony periodontal defects - Extraction socket grafting
    Device Description
    C-GRAFT™ is a bone filling and augmentation matcrial indicated for use in dental applications. C-GRAFT™ is an inorganic, biocompatible calcium phosphate material derived from calcium-encrusted red sea algae. The algae are processed in order to develop an apatite material that is analogous to bone apatite. C-GRAFT™ is provided sterile in pre-filled vials and has a granule size range from 300-1000 microns.
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