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510(k) Data Aggregation

    K Number
    K052532
    Device Name
    IMAX 9.5 STERILIZERS
    Manufacturer
    Date Cleared
    2006-09-05

    (355 days)

    Product Code
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAL X SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer intended for heat and moisture resistant medical and dental (including complex lumened devices such as dental handpieces) instruments and cloth packs for sterilization in healthcare facilities. Three programmed sterilization cycles are provided with the iMax 9.5 DS Sterilizer (see table below). | Cycle | Temperature<br>(°C) | Pressure<br>(bar) | Exposure<br>Time (min.) | Drying Time<br>(min.) | Maximum<br>Load (kg) | |---------------------------|---------------------|-------------------|-------------------------|-----------------------|----------------------| | Unwrapped<br>instruments* | 134 | 2.14 – 2.21 | 4 | 6 | 4.0 | | Wrapped<br>instruments** | 134 | 2.14 – 2.21 | 20 | 20 | 4.0 | | Packs | 121 | 1.10 - 1.17 | 30 | 20 | 1.5 | * Not indicated for the processing of complex instruments (i.e. containing lumens, hinges, mated surfaces, etc.) ** Dental handpieces can be processed in the Wrapped instruments cycle only The sterilizer is not intended to sterilize patient-contacting liquids.
    Device Description
    The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer. The iMax 9.5 DS Sterilizer is provided with a diaphragm compressor and HEPA filter that circulates filtered air in the sterilization chamber during the drying phase.
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