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510(k) Data Aggregation

    K Number
    K142130
    Device Name
    ORAL BOND
    Date Cleared
    2016-06-06

    (672 days)

    Product Code
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    STEINER LABORATORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Oral Bond is indicated to be used as an adjunct to temporally assist in securing periodontal dressings.
    Device Description
    Oral Bond is a sterile, liquid dental cement containing a monomeric (2-octyl cyanoacrylate) formulation with a viscosity increasing agent, stabilizer, and colorant (D&C Violet #2 or D&C Yellow #10) . Oral Bond is supplied in a multiuse vial. The liquid is syrup-like in viscosity and polymerizes within seconds after contact with water.
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    K Number
    K113049
    Device Name
    SOCKET GRAFT
    Date Cleared
    2012-01-27

    (106 days)

    Product Code
    Regulation Number
    872.3930
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    Applicant Name (Manufacturer) :

    STEINER LABORATORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SOCKET GRAFT is a bone grafting material indicated for use in dental extraction sockets that have all walls remaining. Socket Seal is a temporary implantable material intended for use in the oral cavity to be used as a space maintaining barrier over bone and other tissue. Socket Seal is indicated for use over bone grafts. Socket Seal in indicated for use over extraction sockets in the maxilla and mandible.
    Device Description
    SOCKET GRAFT is intended to regenerate bone in dental extraction sockets. SOCKET GRAFT is dual phase calcium phosphate biocement that is wetted by sterile water to a putty consistency. Extraction sockets are filled with SOCKET GRAFT and covered by the enclosed Socket Seal. SOCKET GRAFT is fully resorbed in 12-14 weeks resulting the extraction socket. SOCKET GRAFT is supplied in sterile, single use 1.5 cc syringes. Socket Seal is a closed cell, medical grade, polyethylene foam material that is a nonporous, biocompatible semi-rigid sheet. Socket Seal is designed to stabilize, support and protect bone graft material and provide space maintenance for regenerative healing.
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    K Number
    K101718
    Device Name
    OSSEOCONDUCT
    Date Cleared
    2010-10-26

    (130 days)

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

    STEINER LABORATORIES DIV OF STEINER HEALTHCARE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OsseoConduct is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. Specifically, for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including ridge augmentation, sinus lifts, craniofacial augmentation, filling of defects of endodontic origin, filling of cystic defects, filling of extraction sites, filling of lesions of periodontal origin, repair of traumatic defects of the alveolar ridge, filling of resection defects from bone tumors, cysts or other osseous defects, and a substitute for autogenous or allogenic bone grafts.
    Device Description
    Not Found
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    K Number
    K063010
    Device Name
    REGEN BIOCEMENT
    Date Cleared
    2006-11-28

    (57 days)

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

    STEINER LABORATORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    REGEN BIOCEMENT is intended to be used as a bone grafting material in the maxillofacial region.
    Device Description
    Not Found
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    K Number
    K052493
    Device Name
    SOCKET GRAFT
    Date Cleared
    2006-06-09

    (270 days)

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

    STEINER LABORATORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Bone void filler for use in dental extraction sockets
    Device Description
    Not Found
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