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510(k) Data Aggregation

    K Number
    K992893
    Device Name
    DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE
    Manufacturer
    MRLB INTL., INC.
    Date Cleared
    1999-09-08

    (12 days)

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

    MRLB INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DentaPure® DP90 and DP365 Cartridge is for use on dental unit water lines attached to the Second handpiece, three-way air/water syringe and dynamic demail mstruments, f.e., mgr. opod has with currently recommended practices regarding ultrasonic Scaler. This outhego in setyantator stermization and Instilling of contax morent ADA recommendations for water quality having a maximum of 200 cfu/ml.
    Device Description
    The DentaPure® DP90 and DP365 Cartridges are in-line assemblies incorporating iodinated resin and a polypropylene filter. The cartridge is connected to the municipal water supply at the air/water service junction box in each operatory. It consists of a polypropylene in-line filter with the inner chamber filled with an iodinated ion exchange resin that imparts 2-6 ppm of iodine into the water as it flows through. The filter portion is of a sufficiently small porosity to retain water-born particulate, and would thereby reduce the amount of particulate that would reach the patient from the dental water system. The iodine that is released reduces biofilm and the chance of cross contamination by introducing the germicide, iodine, into the water system downstream of the filter. The DentaPure® Cartridge is a disposable unit, retrofittable to all modern dental operatory units.
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    K Number
    K992868
    Device Name
    DENTAPURE DP40 CARTRIDGE
    Manufacturer
    MRLB INTL., INC.
    Date Cleared
    1999-09-07

    (12 days)

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

    MRLB INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DentaPure® DP40 Cartridge is for use on dental unit water lines attached to the dynamic dental instruments, i.e., high-speed handpiece, three-way air/water syringe and ultrasonic scaler. This cartridge in conjunction with currently recommended practices regarding sterilization and flushing of dental instruments reduces bacteria from the water supplied through the instruments to a level that will meet or exceed the current ADA recommendations for water quality having a maximum of 200 cfu/ml.
    Device Description
    The DentaPure® DP40 Cartridge is an in-line assembly incorporating iodinated resin and a polyolefin filter. The cartridge is connected to the pickup tube of a bottle water system. It consists of a polyolefin in-line filter with the inner chamber filled with an iodinated ion exchange resin that imparts 2-6 ppm of iodine into the water as it flows through. The filter portion is of a sufficiently small porosity to retain water-born particulate, and would thereby reduce the amount of particulate that would reach the patient from the dental water system. The iodine that is released reduces biofilm and the chance of cross contamination by introducing the germicide, iodine, into the water system downstream of the filter. The DentaPure® Cartridge is a disposable unit, retrofittable to all modern dental operatory units with independent bottle water systems. The cartridge is installed in the bottle reservoir tubing with quick connect fittings for ease of change.
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    K Number
    K963548
    Device Name
    DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED
    Manufacturer
    MRLB INTL., INC.
    Date Cleared
    1997-01-22

    (139 days)

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

    MRLB INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DentaPure™ Cartridge is an in-line filter assembly Incorporating iodinated resin and a .22 micron filter. The filter incorporating fournated roshe connection to the handpiece. This is illustrated in Figure 1.
    Device Description
    The DentaPure™ Cartridge is an in-line filter assembly Incorporating iodinated resin and a .22 micron filter. It consists of A schematic of the cartings is vith the outer chamber filled with a lichiorane type in mage resin that imparts 2-4 ppm of iodine into the water as it flows through. The filter portion is of a sufficiently small porosity to be bacterially retentive, and would thereby reduce the amount of bacteria that would reach the patient from the dental water system. The iodine that is released reduces the chance of cross contamination by introducing the germicide, iodine, into the water system downstream of the filter. The DentaPure™ Cartridge is a disposable unit, retrofittable to all modern dental operatory units. The filter is installed in each dynamic instrument water tubing with quick connect fittings for ease of changing on a weekly basis.
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