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510(k) Data Aggregation

    K Number
    K151149
    Device Name
    Ready-Fit
    Manufacturer
    DENTEK ORAL CARE, INC.
    Date Cleared
    2015-09-30

    (153 days)

    Product Code
    OBR
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTEK ORAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ready-Fit Disposable Dental Guard is indicated for protection for nighttime teeth grinding or bruxism. It is intended to reduce damage to teeth by cushioning them and keeping them apart during grinding.
    Device Description
    Ready-Fit Disposable Dental Guard is a ready-to-wear, posterior-only occlusive mouthquard, with two molar bite surfaces each consisting of three cylinders (bite tubes) connected by a buccal retention band.
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    K Number
    K130186
    Device Name
    DENTEK EASY BRUSH WITH FLUORIDE
    Manufacturer
    DENTEK ORAL CARE, INC.
    Date Cleared
    2013-07-15

    (171 days)

    Product Code
    EFW
    Regulation Number
    872.6855
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTEK ORAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Easy Brush with fluoride is intended to mechanically remove plaque and food particles from between teeth to reduce tooth decay. It is to be used with an in and out motion to clean between interdental space as it is done with floss, and other interdental cleaners such as tooth picks.
    Device Description
    The Easy Brush with fluoride is an interdental brush designed to clean between teeth. It is composed of 4 parts (a handle, a wire, bristles, and a cap). The wire is twisted around the nylon filaments to create the brush, and then is molded onto a plastic handle. It is then coated with a solution containing flavor and sodium fluoride and then capped off.
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    K Number
    K123849
    Device Name
    NEW COMFORT-FIT DENTAL GUARD
    Manufacturer
    DENTEK ORAL CARE, INC.
    Date Cleared
    2013-01-10

    (27 days)

    Product Code
    OBR
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTEK ORAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The New Comfort-Fit® Dental Guard is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.
    Device Description
    The New Comfort-Fit® Dental Guard is a posterior-only occlusion dental guard, consisting of two bite pads connected by a buccal retention strap. The New Comfort-Fit® consists entirely of ELVAX, a thermoplastic material. The bite pads move along the buccal strap in order to adjust to the individual user needs, with the strap always contained within the walls of the bite pads. There are 5 positions of adjustability for each bite pad. Bumpers on the lingual wall of the bite pads keep the pads from rubbing against the lower gum line. The upper vertical bite pad wall creates a greater surface area for the cheek to rest against, providing enhanced retention for the guard.
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    K Number
    K091660
    Device Name
    CUSTOM COMFORT NIGHTGUARD VERSION 2
    Manufacturer
    DENTEK ORAL CARE, INC.
    Date Cleared
    2009-06-12

    (3 days)

    Product Code
    OBR
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTEK ORAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Custom Comfort Nightguard Version 2 is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
    Device Description
    The Custom Comfort Nightguard Version 2 is a fully occlusive nightguard, consisting of a soft, formable material, and non-formable base, which cushions the teeth. When heated and then briefly cooled, the formable material is molded to fit the user's maxillary dentition for maximum retention. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing and cushions the teeth on all occlusal surfaces.
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    K Number
    K083400
    Device Name
    CUSTOM COMFORT NIGHTGUARD
    Manufacturer
    DENTEK ORAL CARE, INC.
    Date Cleared
    2008-12-11

    (24 days)

    Product Code
    OBR
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTEK ORAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Custom Comfort Nightguard is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
    Device Description
    The Custom Comfort Nightguard is a fully occlusive nightguard, consisting of a soft, formable material, and non-formable base, which cushions the teeth. When heated and then briefly cooled, the formable material is molded to fit the user's maxillary dentition for maximum retention. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing and cushions the teeth on all occlusal surfaces. The Custom Comfort is designed with an anterior area formed from the soft, formable material that allows for expansion and contraction of the device to fit most mouth sizes.
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    K Number
    K081669
    Device Name
    IMPROVED COMFORT-FIT NIGHTGUARD
    Manufacturer
    DENTEK ORAL CARE, INC.
    Date Cleared
    2008-07-10

    (27 days)

    Product Code
    OBR
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTEK ORAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DenTek Improved Comfort-Fit NightGuard is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
    Device Description
    The Improved Comfort-Fit NightGuard is a posterior-only occlusion nightguard, consisting of two bite pads connected by a buccal retention strap. The Improved Comfort-Fit consists entirely of ELVAX, a thermoplastic material. The bite pads move along the buccal strap in order to the individual user needs, with the strap always contained within the wings of the bite pads. There are 5 positions of adjustability for each molar pad.
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    K Number
    K063483
    Device Name
    DEN TEK NIGHTGUARD
    Manufacturer
    DENTEK ORAL CARE, INC.
    Date Cleared
    2007-01-23

    (67 days)

    Product Code
    MQC
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTEK ORAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DenTek NightGuard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or teeth grinding.
    Device Description
    The DenTek NightGuard is composed of a soft, formable material made of a blend of ethylene vinyl acetates, and non-formable occlusal base, which cushions the teeth. The base is composed of a copolymer of ethylene and methyl acrylate. When heated and then briefly cooled, the formable material is molded to fit the user's upper teeth for maximum retention. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing and cushions the teeth on all occlusal surfaces. The DenTek NightGuard is designed with three flex points that allow for expansion and contraction of the device to fit most mouth sizes.
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