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510(k) Data Aggregation

    K Number
    K051047
    Device Name
    COLLOSS E BONE VOID FILLER
    Manufacturer
    OSSACUR AG
    Date Cleared
    2006-03-08

    (317 days)

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

    OSSACUR AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    COLLOSS E is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. COLLOSS E is resorbed and replaced with bone during the healing process.
    Device Description
    COLLOSS E is a bone void filler extracted from the extracellular n diaphyseal equine bone. It is a lyophilizate in collagenous matrix form, consisting of collagen Type I chains with other insoluble proteins present. COLLOSS E is dry with a cotton-like appearance, having a white to slightly yellowish color. The product is processed under aseptic conditions and is nonpyrogenic. It is supplied in a 20 mg quantity, packaged in a vial inside of a Tyvek pouch. The inner surfaces of the pouch are terminally sterilized by plasma sterilization.
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    K Number
    K053374
    Device Name
    OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)
    Manufacturer
    OSSACUR AG
    Date Cleared
    2006-02-21

    (78 days)

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

    OSSACUR AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OSSAPLAST DENTAL is intended for use in filling, augmenting, or reconstructing periodontal or bony defects of the oro-maxillofacial region. It is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge. - Filling of 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 GBR.
    Device Description
    OSSAPLAST DENTAL is a synthetic, implantable, resorbable, radiopaque βtricalcium phosphate (β-ΤCP) ceramic in granulate form. It consists of purephase β-ΤCP [Саз(РОд)½] and is csteoconductive, with high interconnecting porosity. OSSAPLAST DENTAL is supplied sterile in sealed glass vials, in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.
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    K Number
    K050416
    Device Name
    OSSAPLAST ORTHO
    Manufacturer
    OSSACUR AG
    Date Cleared
    2005-03-29

    (39 days)

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

    OSSACUR AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, illium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process.
    Device Description
    OSSAPLAST ORTHO (1000 – 2000 µm) is a synthetic, implantable, resorbable, radiopaque β-tricalcium phosphate (β-ΤCP) ceramic in granulate form. It consists of pure-phase β-ΤСР [Саз(РОд)չ] and is osteoconductive, with high interconnecting porosity. OSSAPLAST ORTHO (1000 – 2000 µm) is supplied sterile in sealed glass vials, in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.
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    K Number
    K042305
    Device Name
    OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903
    Manufacturer
    OSSACUR AG
    Date Cleared
    2004-10-21

    (57 days)

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

    OSSACUR AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process.
    Device Description
    OSSAPLAST ORTHO is a synthetic, implantable, resorbable, radiopaque ß-tricalcium phosphate (β-ΤCP) ceramic in granulate form (particle size of 500 - 1000 µm). It consists of pure-phase ß-TCP [Ca3(PO4)2] and is osteoconductive, with high interconnecting porosity. OSSAPLAST ORTHO is supplied sterile in sealed glass vials in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.
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