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510(k) Data Aggregation

    K Number
    K102526
    Device Name
    BLO2X OXYGEN BLOCKER
    Manufacturer
    Date Cleared
    2010-10-22

    (50 days)

    Product Code
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    PASCAL CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BLO2X Oxygen Blocker is intended to prevent negative contour in areas where oxygen inhibition of resin polymerization results in premature material loss. Use it before curing composites or luting to prevent the oxygen inhibition layer from forming. BLO2X Oxygen Blocker allows removal of luting resins closer to the final contour before curing, thus eliminating the need to address a large excess of cured composite or luting cement.
    Device Description
    BLO2X Oxygen Blocker is a clear, glycerin-based gel containing a viscosity-inducing agent, producing a gel with similar viscosity characteristics to the predicate product.
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    K Number
    K090597
    Device Name
    FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH
    Manufacturer
    Date Cleared
    2009-03-16

    (11 days)

    Product Code
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    PASCAL CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive root surfaces.
    Device Description
    The modified varnish has the following similarities to that which previously received 510(k) concurrence: - Has the same active ingredient at the same concentration; . - has the same indications for use; . - incorporate the same or similar materials; . - has the same shelf life, and; ● - is packaged using the same materials and processes.
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    K Number
    K040988
    Device Name
    ZIRCON-F PROPHYLAXIS PASTE
    Manufacturer
    Date Cleared
    2004-07-07

    (83 days)

    Product Code
    Regulation Number
    872.6030
    Why did this record match?
    Applicant Name (Manufacturer) :

    PASCAL CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
    Device Description
    Zircon-F Prophylaxis Paste
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    K Number
    K040661
    Device Name
    RADENT PROPHY PASTE
    Manufacturer
    Date Cleared
    2004-06-09

    (89 days)

    Product Code
    Regulation Number
    872.6030
    Why did this record match?
    Applicant Name (Manufacturer) :

    PASCAL CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
    Device Description
    Not Found
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    K Number
    K012889
    Device Name
    BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT
    Manufacturer
    Date Cleared
    2003-05-27

    (637 days)

    Product Code
    Regulation Number
    880.6885
    Why did this record match?
    Applicant Name (Manufacturer) :

    PASCAL CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Banicide® Advanced is a reusable liquid chemical sterilant/high level disinfectant intended to (1) sterilize medical instruments at an exposure time of 10 hours and an exposure temperature of 25℃ and a minimum effective concentration of 1.8% glutaraldehyde; and (2) provide high level disinfection at an exposure time of 45 minutes and an exposure temperature of 25°C and a minimum effective concentration of 1.8% glutaraldehyde. It may be re-used for a period of 30 days provided the solution remains above the MEC as confirmed by a chemical indicator test strip.
    Device Description
    Single container glutaraldehyde solution for sterilization and high level disinfection
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    K Number
    K030488
    Device Name
    FLUORILAQ
    Manufacturer
    Date Cleared
    2003-05-02

    (77 days)

    Product Code
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    PASCAL CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Int inded for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive roc t surfaces.
    Device Description
    Not Found
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