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510(k) Data Aggregation

    K Number
    K214057
    Device Name
    STATIM 6000B Vacuum Autoclave
    Manufacturer
    SciCan Ltd.
    Date Cleared
    2022-03-31

    (94 days)

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

    SciCan Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STATIM 600B are dynamic air removal (pre-vacuum) table-top steam sterilizers that are intended for use by a healthcare provider to sterilize medical products by means of pressurized steam. The STATIM 6000B are suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATIM 6000B has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such in incomplete sterlization and/or damage to the autoclave.
    Device Description
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    K Number
    K210326
    Device Name
    Bravo G4 Chamber Autoclave
    Manufacturer
    SciCan Ltd.
    Date Cleared
    2021-07-01

    (147 days)

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

    SciCan Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BRAVO G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterlizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be steam. The BRAVO G4 has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.
    Device Description
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    K Number
    K192910
    Device Name
    STATClave G4 Chamber Autoclave
    Manufacturer
    SciCan Ltd.
    Date Cleared
    2020-06-19

    (248 days)

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

    SciCan Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STATCLAVE G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.
    Device Description
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    K Number
    K190062
    Device Name
    STATCLAVE G4 Chamber Autoclave
    Manufacturer
    SciCan Ltd.
    Date Cleared
    2019-07-26

    (192 days)

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

    SciCan Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STATCLAVE G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.
    Device Description
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    K Number
    K172292
    Device Name
    SALUS - Hygiene Instrument Reprocessing Container
    Manufacturer
    SciCan Ltd.
    Date Cleared
    2017-11-24

    (116 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    SciCan Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SALUS® - Hygiene is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The SALUS® - Hygiene is a reusable instrument reprocessing container intended to enclose and organize instruments that are designed to withstand steam sterilization and to maintain sterility of the reusable instruments during storage. The SALUS - Hygiene is suitable for use in dynamic air removal steam sterilizers.
    Device Description
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    K Number
    K112872
    Device Name
    STATIM 2000 G4 CASSETTE
    Manufacturer
    SCICAN LTD.
    Date Cleared
    2012-07-10

    (284 days)

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

    SCICAN LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STATIM 2000/5000 G4 Cassette Autoclaves are steam flush pressure pulse dynamic air removal steam autoclaves designed for the reprocessing of reusable medical instruments to achieve successful sterilization in a clinical setting. They utilize saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms. The units are intended to sterilize heat and moisture stable medical instruments (including handpieces) which are commonly found in medical and dental offices, hospitals, clinics, and other facilities. The STATIM 2000/5000 G4 Cassette Autoclaves are only intended for heat stable instruments.
    Device Description
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    K Number
    K090937
    Device Name
    E-STATIS 40 SYSTEM
    Manufacturer
    SCICAN LTD.
    Date Cleared
    2009-07-24

    (112 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCICAN LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The E-STATIS type 40 dental system is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures. The E-STATIS 40 System is intended for use in dentistry for restoration, prophylaxis and endodontic procedures. The system provides control for motorized handpieces by converting pneumatic output from the dental treatment center to permit the operation of electrically driven dental handpieces.
    Device Description
    The E-STATIS type 40 Electric Motor System is designed for use in various dental procedures including dental restoration, prophylaxis and endodontics. The system is comprised of a power supply, control unit, hose and a brushless micro motor. The control unit is equipped with five customizable endo settings including torque control, with the option of auto-stop, auto-forward and auto-reverse-forward. In addition, there are also three standard customizable operative modes. All E-STATIS components are modular and can be placed wherever the operator chooses. The inputs to the control unit are supplied by a control panel with touch screen operation. The touch-sensitive screen has clear, user friendly symbols and provides individual selection and usage of the parameters to the individual needs of the dentist. The touch pad is removable and can be mounted either internally or externally on the dental unit.
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    K Number
    K090265
    Device Name
    BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V
    Manufacturer
    SCICAN LTD.
    Date Cleared
    2009-05-15

    (101 days)

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

    SCICAN LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BRAVO series of Autoclaves are intended to be used in medical and dental practices, hospitals, clinics and other associated facilities to sterilize re-usable medical and dental instruments (including dental handpieces) and medical materials that are heat and moisture resistant and compatible with the steam sterilization process. The BRAVO series of Autoclaves are not intended nor recommended for the sterilization of fluids, liquids, or pharmaceutical products.
    Device Description
    The BRAVO series of Autoclaves are table-top vacuum steam sterilizers designed to process medical and dental instruments to achieve successful sterilization. The units utilize saturated steam at high pressures and temperatures to attain an effective kill of infectious bio-organisms. BRAVO autoclaves are equipped with either a 17 or 21 litre sterilization chamber and feature an advanced fractionated vacuum system to achieve complete air removal from the sterilization chamber and effective final vacuum drying with an effective final vacuum to minimize the presence of condensation from the finished load. Instruments are placed onto a sterilization tray which is then inserted into the sterilization chamber and the unit is closed. One of the ten pre-set sterilization cycles is selected and the unit is started. The units are fully automatic for the complete sterilizing cycle. An exclusive steam generation system, combined with an advanced control system, guarantees optimal thermodynamic parameters during the entire sterilization process. The devices offer sterilization programs optimized for the effective and fast sterilization of various instruments and materials used in the medical and dental environments. Depending on the preset cycle chosen, the devices will progress through a series of pulses which consist of one to three vacuum draws followed by pressurization to create steam in order to remove any air from the sterilization chamber. They will then maintain the projected sterilization time, vent down to atmospheric conditions and begin a heated vacuum dry cycle that will run for a predetermined period of time depending on the model as well as the cycle selected. The devices then return to atmospheric conditions so that the door can be opened to remove the processed load.
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    K Number
    K073319
    Device Name
    STATMATIC 31 HANDPIECE MAINTENANCE UNIT
    Manufacturer
    SCICAN LTD.
    Date Cleared
    2008-02-04

    (70 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCICAN LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K072466
    Device Name
    STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101
    Manufacturer
    SCICAN LTD.
    Date Cleared
    2007-12-19

    (106 days)

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

    SCICAN LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STATIM 7000 Cassette Autoclave is a pressure pulse steam autoclave designed to process medical and dental instruments to achieve successful sterilization in a clinical setting. It utilizes saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection. The unit is intended to sterilize heat and moisture stable medical and dental instruments (including dental handpieces) that are commonly found in medical and dental offices, hospitals, clinics, and other facilities. The instruments must be suitable for steam sterilization at 134℃ (273%) or 121 °C (250°F). The STATIM 7000 Cassette Autoclave is not intended nor recommended for the sterilization of liquids, cloths, text les, biomedical waste and certain rubber and plastic materials specified in the Operator's Manual. The sterilization cycles as to established times, temperatures and indicated uses for the STATIM 7000 Cassette Autoclave are as follows: | CYCLE | TEMPERATURE | NO. OF PURGES | STERILIZATION TIME | INTENDED USE | |-------------------|----------------|---------------|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | UNWRAPPED | 134°C (273°F) | 3 | 3.5 min. | Solid instruments, hinged<br>instruments, dental handpieces, with<br>drying | | WRAPPED | 134°C (273°F) | 6 | 3.5 min. | Solid, hollow (including dental<br>handpieces) & hinged instruments<br>wrapped in paper/paper or<br>paper/plastic pouches or paper<br>sterilization wrap, with improved<br>drying performance | | RUBBER & PLASTICS | 121°C (250°F). | 3 | 30 min. | Instruments of rubber & plastic<br>construction (exceptions are listed in<br>the Operator's Manual) with drying |
    Device Description
    The STAT/M 7000 Cassette Autoclave is a pressure pulse steam autoclave designed to process medical and dental instruments to achieve successful sterilization. The unit utilizes saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection. Instruments are placed within the provided cassette, the cassette is placed within the armature, the cycle parameters are selected and the start button depressed. The unit is then fully automatic for the complete sterilizing cycle.
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