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510(k) Data Aggregation

    K Number
    K000149
    Device Name
    NOVABONE-BIOGLASS BONE GRAFT PARTICULATE
    Manufacturer
    U.S. BIOMATERIALS CORP.
    Date Cleared
    2000-02-07

    (19 days)

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

    U.S. BIOMATERIALS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992416
    Device Name
    PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE
    Manufacturer
    U.S. BIOMATERIALS CORP.
    Date Cleared
    1999-10-15

    (87 days)

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

    U.S. BIOMATERIALS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of PerioGlas is to provide a safe, biocompatible synthetic bone graft material for oral/maxillofacial and dental intraosseous defects use. It is to be used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (DFDBA demineralized freeze dried bone) or may be mixed with each as a bone graft extender. Typical uses include: - Periodontal/Infrabony defects . - Ridge augmentation . - Extraction sites . - Cranio-facial augmentation . - Cystic cavities . - . Sinus lifts
    Device Description
    PerioGlas® is a synthetic osteoconductive particulate bone/void filler that is intended for oral/maxillofacial and dental intraosseous defects use. The material composed of Bioglass® (24.5 wt % CaO, 24.5 wt % Na20, 45 wt % SiO2, 6 wt % P2O5) with a particle size range of 90-710 um. It is supplied sterile in a Tyvek sealed PET-G cup that is protected by a shrink wrapped cardboard box. It is mixed with sterile water (saline) or the patient's own blood to form a wet sandy paste which is applied to the defect.
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    K Number
    K962494
    Device Name
    PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE
    Manufacturer
    U.S. BIOMATERIALS CORP.
    Date Cleared
    1996-09-20

    (86 days)

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

    U.S. BIOMATERIALS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Perioglas® is indicated for use in infraboney pockets caused by periodontal disease. The intended uses have been extended to extraction sites and ridge augmentation.
    Device Description
    Perioglass® Bone Graft Particulate is a bioactive glass particulate (90-710 microns).
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