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510(k) Data Aggregation

    K Number
    K094026
    Device Name
    STERI-DENT, STERI-SURE
    Manufacturer
    CPAC, INC.
    Date Cleared
    2011-07-12

    (559 days)

    Product Code
    KMH
    Regulation Number
    880.6870
    Why did this record match?
    Product Code :

    KMH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model 2100 and 3100 are table-top natural convective (static air type) dry heat sterilizers designed for use in healthcare facilities for the sterilization of wrapped and unwrapped metal instruments. The single sterilization cycle runs at 160°C (320°F) for 1 hour (60 minutes).
    Device Description
    The Model 2100 and 3100 are table-top natural convective (static air type) dry heat sterilizers designed for use in healthcare facilities for the sterilization of wrapped and unwrapped metal instruments and glassware. The single sterilization cycle runs at 160°C (320°F) for 1 hour (60 minutes). Items to be sterilized are placed horizontally on the removable trays inside the chamber. Both models are plug-in units designed to run on standard 115 VAC household current. A thermocouple is used to measure the chamber temperature. All functions of the sterilizer are controlled by an embedded PCB. Access to the heating chamber is through a hinged door on the front of unit. A LED digital display located on the front of the unit indicates chamber temperature and remaining cycle time.
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    K Number
    K051660
    Device Name
    DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    2005-08-04

    (43 days)

    Product Code
    KMH
    Regulation Number
    880.6870
    Why did this record match?
    Product Code :

    KMH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DDS 7000 is a countertop convective dry heat sterilizer designed for use in Healthcare facilities for the sterilization of un-bagged dental instruments that can withstand exposure temperatures up to 216°C (420° F). There is a single software-controlled cycle that includes a warm-up and cool down phase in addition to the 3-minute sterilization (exposure) phase. Sterilize (exposure) starts when the RTD/control temperature reaches the operating temperature set point of 190°C (374° F). Complete cycle times average 34-44 minutes and are load dependent. The DDS 7000 achieves optimum results by uniform load distribution utilizing a dedicated rack and tray system as detailed below. 1) Maximum recommended loads validated for the DDS 7000-115 sterilizer: - a) Maximum load for a four (4)-rack configuration is four (4) plier racks each holding nine (9) orthodontic pliers each for a total of thirty-six (36) pliers. Other maximum load configuration options are: 32 pliers on eight mini vertical racks; or 20 pliers and hand instruments on four Combo Racks -(OR)- b) Maximum load for a full tray configuration is one (1) Horizontal Tray each holding up to six (6) orthodontic pliers or up to (12) single-handle hand instruments. Other maximum load combinations include: (5) orthodontic pliers with up to (2) single-handle hand instruments; or (4) orthodontic pliers with up to (4) single-handle hand instruments; or (3) orthodontic pliers with up to (6) single-handle hand instruments, or (2) Orthodontic pliers with up to (8) single-handle hand instruments; or (1) Orthodontic pliers with up to (10) single-handle hand instruments. - (OR)- c) Maximum load for the one (1) half tray and two (2) racks is one (1) Half Tray holding three (3) Orthodontic pliers or six (6) single-handle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks. Other maximum load combinations include: (2) orthodontic pliers with up to (2) single-handle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks; or (1) orthodontic pliers with up to (4) singlehandle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks.
    Device Description
    The DDS 7000, like the DDS 5000 is a convective dry heat batch sterilizer capable of sterilizing un-bagged dental instruments and cooling them for immediate use. It is designed for use with a dedicated rack system that provides for uniform loading to achieve optimum load distribution. The DDS 7000 is equipped with a replaceable HEPA filter to comply with ANSI/AAMI ST50: 2004 cooling requirements. The HEPA filter has a filtration efficiency of 99.7% for 0.3-micron particles. The DDS 7000 is a software-controlled device that allows for the user to preprogram options such as display units (Celsius or Fahrenheit), audible alarm enabled/disabled and safety interlock enabled/disabled The DDS 7000 monitors the entire cycle and will provide diagnostic error codes in the event of any failure or disruption to the sterilization cycle. A printable log is available for the most recently performed cycle that includes pass/fail notification and error codes if applicable
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