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510(k) Data Aggregation

    K Number
    K091533
    Device Name
    SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200
    Date Cleared
    2009-08-17

    (83 days)

    Product Code
    Regulation Number
    872.4565
    Why did this record match?
    Product Code :

    JEP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is used in combination with other dental devices to retain composite or amalgam restorative materials during dental restorations.
    Device Description
    Matrix bands are used to retain composite and other restorative materials during dental restorations. In general a matrix band surrounds the tooth and is used to separate the teeth while a composite filling is placed. The type of band is selected based on the tooth height and restoration type. The dentist prepares the tooth and places the band on the tooth. A wedge is inserted for optimal contour, gingival seal, and tooth separation. A ring retainer such as the Composi-Tight 3D Ring or Composi-Tight 3D Thin Tine G Ring is used to hold the band in place. The band is removed after the application of composite resin. The devices are offered in different thicknesses, lengths, and widths to accommodate different sized teeth. Additionally, the device is offered in soft stainless steel and hard stainless steel depending on the preference of the dentist. The devices are offered in sectional matrix style or standard style (Tofflemire style). The Tofflemire style is a longer thinner band with or without lobes. The choice of style is dependent on the preference of the dentist and the specific condition and size of the patient's teeth.
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