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510(k) Data Aggregation

    K Number
    K111087
    Device Name
    FOUNDATION
    Manufacturer
    OLYMPUS TERUMO BIOMATERIALS CORPORATION
    Date Cleared
    2011-11-29

    (224 days)

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

    OLYMPUS TERUMO BIOMATERIALS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FOUNDATION device is a collagen-based bone filling augmentation material for use in filling of extraction sockets.
    Device Description
    The FOUNDATION bone filler device is a sponge-like absorbable natural collagen plug designed to be used as indicated. FOUNDATION consists of approximately 85-95% Type I collagen and approximately 5-15% Type III collagen from bovine dermis.
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    K Number
    K081561
    Device Name
    OSFERION D
    Manufacturer
    OLYMPUS TERUMO BIOMATERIALS CORPORATION
    Date Cleared
    2008-07-28

    (55 days)

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

    OLYMPUS TERUMO BIOMATERIALS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. - 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
    OSferion D is a white porous material composed of Beta-tricalcium phosphate(ß-TCP). It is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. The ceramic material complied with US standard specification ASTM F 1088-04. The OSferion D product range consists of two product types with porosities of 75% and of three granule sizes (G0:0.15~0.8mm,G1:0.5~1.5mm,G2:1.0~3.0mm).
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    K Number
    K080065
    Device Name
    OSFERION
    Manufacturer
    OLYMPUS TERUMO BIOMATERIALS CORPORATION
    Date Cleared
    2008-05-02

    (113 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    OLYMPUS TERUMO BIOMATERIALS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
    Device Description
    OSferion is a white porous material composed of ß-tricalcium phosphate(ß-TCP). It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. OSfenon is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The OSferion product range consists of two product types with porosities of 75% and 60%. Products are supplied in blocks, cylinders, granules and wedges.
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