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    K Number
    K100182
    Device Name
    SALVIN DENTAL SPECIALTIES FIXATION SCREW
    Manufacturer
    SALVIN DENTAL SPECIALTIES, INC.
    Date Cleared
    2010-05-10

    (109 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Applicant Name (Manufacturer) :

    SALVIN DENTAL SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Salvin Bone Tack System is designed to stabilize a barrier membrane onto a region of cortical plate. This may be used in craniofacial, maxillofacial, or mandibular bone. Considerations such as quality of bone, bone type, functional loads exerted, general patient health and others should be carefully evaluated prior to use.
    Device Description
    The Salvin Bone Tack System consists of 3mm and 5mm Titanium (Ti-6Al-4V) bone tacks and associated instrumentation. The devices are provided non-sterile.
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    K Number
    K073342
    Device Name
    SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW
    Manufacturer
    SALVIN DENTAL SPECIALTIES, INC.
    Date Cleared
    2008-03-26

    (119 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Applicant Name (Manufacturer) :

    SALVIN DENTAL SPECIALTIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use in internal fixation of small bones including the craniofacial and maxillofacial skeleton affected by trauma, or for reconstruction. Single patient use only
    Device Description
    The Salvin Dental Specialties Titanium Fixation Screw System consists of 1.5mm and 2.0mm Titanium (Ti-6Al-4V) bone screws in lengths of 4, 6, 8, 10, 13 and 15mm. The 2.0mm diameter screws are “emergency” screws. The devices are provided non-sterile.
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