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510(k) Data Aggregation

    K Number
    K073518
    Device Name
    FLASHLITE REBEL*
    Manufacturer
    DISCUS DENTAL, INC.
    Date Cleared
    2007-12-20

    (6 days)

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

    DISCUS DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K033785
    Device Name
    PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE
    Manufacturer
    DISCUS DENTAL, INC.
    Date Cleared
    2004-06-18

    (197 days)

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

    DISCUS DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
    Device Description
    The ProActive Carem is a premium Prophylaxis Paste with fluoride that gently removes dental plaque and staining. It is a unique blend of polishing and cleaning agents designed for professional application during standard dental practice hygiene procedures.
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    K Number
    K030776
    Device Name
    MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL
    Manufacturer
    DISCUS DENTAL, INC.
    Date Cleared
    2003-05-09

    (59 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
    Mega Bite is designed for making accurate occlusal records.
    Device Description
    Not Found
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    K Number
    K023748
    Device Name
    FLASH-LITE II LED DENTAL CURING LIGHT
    Manufacturer
    DISCUS DENTAL, INC.
    Date Cleared
    2003-01-17

    (70 days)

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

    DISCUS DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Source of illumination for curing photo-activated, visible light cured dental restorative materials.
    Device Description
    Not Found
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    K Number
    K022184
    Device Name
    FLASH-LITE LED DENTAL CURING LIGHT
    Manufacturer
    DISCUS DENTAL, INC.
    Date Cleared
    2002-08-20

    (48 days)

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

    DISCUS DENTAL, INC.

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

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