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510(k) Data Aggregation

    K Number
    K062176
    Device Name
    RELIEF ACP ORAL CARE GEL
    Manufacturer
    DISCUS DENTAL INC.
    Date Cleared
    2007-01-10

    (163 days)

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

    DISCUS DENTAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relief ACP Oral Care Gel is indicated for relief of discomfort from dentin sensitivity. The product works by forming a layer of calcium phosphate and potassium nitrate on teeth.
    Device Description
    Relief ACP Oral Care Gel
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    K Number
    K052090
    Device Name
    SPLASH! IMPRESSION MATERIAL DEVICE
    Manufacturer
    DISCUS DENTAL INC.
    Date Cleared
    2005-08-05

    (3 days)

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

    DISCUS DENTAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Splash!® Dental Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.
    Device Description
    Splash!® Dental Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material. It is available in Regular set or fast-setting Half-time varieties. Both are available in a heavy viscosity and in wild berry flavor, as well as unflavored.
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    K Number
    K051776
    Device Name
    PROTEGE ULTRASONIC INSERT
    Manufacturer
    DISCUS DENTAL INC.
    Date Cleared
    2005-07-13

    (12 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    DISCUS DENTAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Protégé Ultrasonic Inserts, both 25KHz and 30KHz models, are intended to be used in the handpieces of any magnetostrictive ultrasonic scaler for dental cleaning and the removal of tenacious calculus deposits by application of an ultrasonic vibrating tip to the teeth.
    Device Description
    Protégé Ultrasonic Insert Devices
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    K Number
    K040053
    Device Name
    PRECISION VPS IMPRESSION MATERIAL
    Manufacturer
    DISCUS DENTAL INC.
    Date Cleared
    2004-03-25

    (73 days)

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

    DISCUS DENTAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Precision VPS Impression Material is intended for use with all crowns, bridges, occlusal and dental impression techniques to reproduce the structure of a patient's teeth and gums.
    Device Description
    Precision VPS Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material available in three different viscosities intended for use with all crowns, bridges, occlusal and dental implant impression procedures.
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    K Number
    K033381
    Device Name
    DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL
    Manufacturer
    DISCUS DENTAL INC.
    Date Cleared
    2004-01-27

    (97 days)

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

    DISCUS DENTAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DisChem™ Chemical Proportioning & Dispensing System, Aquarius model, for use exclusively with Cetlycide-G concentrate and diluent packaged specifically for the DisChem™ system, is intended for dispensing the Cetylcide-G use solution.
    Device Description
    Not Found
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