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510(k) Data Aggregation

    K Number
    K091613
    Device Name
    TAKE 1
    Manufacturer
    KERR CORP.
    Date Cleared
    2009-10-07

    (126 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Take I is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.
    Device Description
    The device is an addition-cure vinyl polysiloxane dental impression material that is used for all crowns and bridges, edentulous, orthodontic and implant impression techniques. Take 1 is a two-part, base/catalyst - paste/paste system. The product is available in three viscosities, Wash, Tray, and Medium.
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    K Number
    K090292
    Device Name
    PREMISE MODIFIED
    Manufacturer
    KERR CORP.
    Date Cleared
    2009-04-03

    (57 days)

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

    KERR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Premise Modified is a dental composite restorative material intended to be used in all classes of cavities.
    Device Description
    The device is a light cured resin based composite dental restorative designed for direct placement. By utilizing three types of fillers, Premise Modified is designed to offer high polishability, high mechanical strength, and decreased polymerization shrinkage.
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    K Number
    K081695
    Device Name
    DMC COMPOSITE
    Manufacturer
    KERR CORP.
    Date Cleared
    2008-08-12

    (56 days)

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

    KERR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DMC Composite High Viscosity is intended for direct restorations of all caries classes. Additional indications include core buildup material, repair of porcelain restorations, and repair of composite restorations. DMC Composite Low Viscosity is intended for Class I and II (base/liner), Class III and Class V restorations. Additional indications include pit and fissure sealant, repair of enamel defects, repair of porcelain restorations, blocking out of undercuts, minor occlusal build-ups in non-stress bearing areas and incisal abrasions.
    Device Description
    DMC Composite is a light-cure resin composite offered in both high viscosity and low viscosity formulations, and is indicated for all caries classes. This product contains 82% filler by weight and is radiopaque.
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    K Number
    K072622
    Device Name
    STANDOUT 2
    Manufacturer
    KERR CORP.
    Date Cleared
    2007-12-04

    (78 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    StandOut 2 is an impression material system intended for use on all crown and bridge, edentulous, orthodontic and implant impressions.
    Device Description
    StandOut 2 is a dental impression material system that is suitable for all crown and bridge, edentulous, orthodontic and impressions StandOut2 is a two-part, base/catalyst -paste/paste system. The product is available in two viscosities, Wash and Tray.
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    K Number
    K042888
    Device Name
    DEMETRON IDS CURING LIGHT
    Manufacturer
    KERR CORP.
    Date Cleared
    2004-11-10

    (22 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Demetron I.D.S. is a L.E.D. visible light curing unit intended for polymerization of light cure materials by dental professionals.
    Device Description
    The LED based Demetron I.D.S. Curing Light is a device used for the polymerization of dental materials. It consists of an LED curing handpiece and flexible cord designed to be connected to a dental chair unit. The plastic molded handpiece will contain an LED light "engine", a cooling fan and a printed circuit board. A digital circuit and microprocessor will be utilized to control 2 different curing modes and power to the LED. Each mode specifies LED curing output timing, fan timing and audible beep timing. A pushbutton "trigger" switch will be used to select the curing mode and activate the LED curing output. The dental chair manufacturer's transformer or power supply will provide power for the handpiece.
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    K Number
    K031484
    Device Name
    STAND OUT
    Manufacturer
    KERR CORP.
    Date Cleared
    2003-07-03

    (52 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stand Out is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous and implant impression techniques.
    Device Description
    The device is an addition-cure vinyl polysiloxane dental impression material that is used for all crowns and bridges, edentulous and implant impression techniques. Stand Out is a two-part, base/catalyst - paste/paste system. The product is available in two viscosities, Wash and Tray.
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    K Number
    K014179
    Device Name
    DEMETRON LC
    Manufacturer
    KERR CORP.
    Date Cleared
    2002-02-04

    (46 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Demetron LC is a visible curing unit intended for polymerization of light cure materials and activation of dental bleaching materials.
    Device Description
    The Demetron LC curing light is a device used for the polymerization of dental materials. It consists of a gun and a base stand connected by a cord. The base stand will contain an on/off switch, a gun hanger, and a beeper that generates an audible tone at ten second intervals. The gun trigger will turn the light on until the trigger is actuated again to turn off. The fan will run continuously whenever the unit is on.
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    K Number
    K010994
    Device Name
    TAKE ONE BITE MODIFIED
    Manufacturer
    KERR CORP.
    Date Cleared
    2001-04-23

    (20 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001655
    Device Name
    PERMLASTIC 2
    Manufacturer
    KERR CORP.
    Date Cleared
    2000-08-10

    (71 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KERR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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