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510(k) Data Aggregation

    K Number
    K981182
    Device Name
    OSTEOGRAF/N-300
    Manufacturer
    CERAMED DENTAL, LLC.
    Date Cleared
    1998-07-02

    (92 days)

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

    CERAMED DENTAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of OsteoGraf/N-300 is for: - Treatment of infrabony periodontal defects. . - Augmentation of bony defects of the alveolar ridge. ● - Filling of extraction sites. - Sinus elevation grafting ●
    Device Description
    OsteoGraf/N-300 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite. the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 250-420 microns.
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    K Number
    K981214
    Device Name
    OSTEOGRAF/N-700
    Manufacturer
    CERAMED DENTAL, LLC.
    Date Cleared
    1998-06-26

    (85 days)

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

    CERAMED DENTAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of OsteoGraf/N-700 is for: - Treatment of infrabony periodontal defects. - Augmentation of bony defects of the alveolar ridge. - Filling of extraction sites. - Sinus elevation grafting.
    Device Description
    OsteoGraf/N-700 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 420-1000 microns.
    Ask a Question

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