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510(k) Data Aggregation

    K Number
    K073040
    Device Name
    SMH FLEX S
    Manufacturer
    SMH BIOMATERIAL AG
    Date Cleared
    2007-12-13

    (45 days)

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

    SMH BIOMATERIAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SMH Flex "S" is intended for the laboratory fabrication of dental prosthesis including the repair and relining of complete and/or partial dentures, occlusal splints, night guards, tooth positioners, snoring and sleep apnea devices, and other appliances as prescribed.
    Device Description
    The submitted device SMH Flex "S" is a pre-mixed acrylic resin for use in the laboratory fabrication of dental prosthesis such as the repair and relining of complete and/or partial dentures, dental appliances including, occlusal splints, night guards, tooth positioners, snoring and sleep apnea devices.
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