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510(k) Data Aggregation

    K Number
    K071245
    Device Name
    TALON AND REVERE
    Manufacturer
    TALON ACRYLICS, INC.
    Date Cleared
    2007-08-02

    (91 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    TALON ACRYLICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TALON and REVERE are a moldable acrylic compound for use in the fabrication, of TMJ/D Splints / Night Guards / Anti-Bruxism Guards / Mouth Guards / Sleep Apnea Anti-Snore Appliances / Liners, and/or Relines for Complete and Partial Dentures / Gaskets for Overdentures / and other dental prostheses device appliances as prescribed.
    Device Description
    The submitted devices, TALON® and REVERE are a thermoplastic moldable acrylic compound for use in the fabrication, repair and relining of complete and/or partial dentures, dental appliances, and dental prostheses devices, including gaskets for over dentures, splints, night guards and sleep apnea anti-snore devices, and other appliances as prescribed.
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