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510(k) Data Aggregation

    K Number
    K091096
    Device Name
    NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100
    Manufacturer
    DENTAL SOLUTIONS, INC.
    Date Cleared
    2009-06-18

    (63 days)

    Product Code
    EIH, ETH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAL SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NaturaZ Series is used in the manufacture of dental prosthetics. The Dental Solution, Inc. proposes that the materials distributed within the United States be labeled: 'CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals."
    Device Description
    NaturaZ Series is a pre-formed material for use by dental laboratories. NaturaZ Series is used in the manufacture of dental prosthetics.
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