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510(k) Data Aggregation

    K Number
    K023815
    Device Name
    C-1805M
    Manufacturer
    Date Cleared
    2003-06-19

    (216 days)

    Product Code
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANODIA SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The C-1805M is designed to clean the dental unit water lines by means of injecting pressurized air and than a solution
    Device Description
    The C-1805M is a pressurized bottle system capable of supplying a solution to the dental unit water lines or pressurized air. The system is used with solutions to clean the dental unit waterlines by air purging the waterlines or injecting a solution. The system can be used to supply water to the dental unit if necessary.
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    K Number
    K023896
    Device Name
    C-1890
    Manufacturer
    Date Cleared
    2003-06-19

    (209 days)

    Product Code
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANODIA SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The C-1890 is designed to clean the dental unit water lines by means of injecting pressurized air and than a solution
    Device Description
    The C-1890 is a pressurized bottle system capable of supplying a solution or pressurized air to the dental unit water lines. The system can be used with solutions to clean the dental unit waterlines by air purging the waterlines and/or injecting a cleaning solution.
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    K Number
    K023213
    Device Name
    RDH-2000
    Manufacturer
    Date Cleared
    2003-01-16

    (112 days)

    Product Code
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANODIA SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Portable pressurized system to deliver a solution to a scalar. Scalar being a dental device powered by air or electricity to remove tartar from the teeth requiring a solution for its performance.
    Device Description
    The RDH-2000 is a portable bottle system. It dispenses solution from its bottle to a scalar. It is attached to the dental unit's quick disconnect air to pressurize the system. The RDH-2000 is composed of two parts; the manifold and the bottle. The manifold has a male quick disconnect. The quick disconnect connects to the dental units air supply via a female air quick disconnect. The system becomes pressurize only when attached to the dental unit. Within the manifold after the male quick disconnect is an internal preset mini air regulator. This is preset at 35 psi. The pressurized air is vented into the bottle via the top of the manifold is a pressure relief button to allow the bottle to be depressurized before unscrewing. The threads in the manifold accept the 28 mm threads of the bottle. A pick up tube goes to the base of the bottle which allows a means for the solution to exit. The pick up tube goes into the manifold and connects to a female quick disconnect with automatic shut-off. The female quick disconnect with the automatic shut-off prevents solution from being dispensed when the system is pressurized. A scalar with a male quick disconnect can attach at this point. This allows the scalar to obtain solution from the bottle. The bottle is a one liter high density polyethylene bottle. The threads have vertical grooves which acts as a pressure relief valve.
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