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510(k) Data Aggregation

    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?
    Product Code :

    EFW

    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
    K121165
    Device Name
    BEAM BRUSH/BEAM APP
    Manufacturer
    BEAM TECHNOLOGIES, LLC
    Date Cleared
    2012-06-21

    (65 days)

    Product Code
    EFW
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    EFW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Beam Brush is a toothbrush to remove plaque and debris from its user's teeth and aide in the prevention of tooth decay. The Beam Brush collects brushing usage data and wirelessly transmits the data to a software application (Beam App) that runs on the user's own mobile device ("smartphone").
    Device Description
    The Beam Brush is a manual toothbrush comprised essentially of a shaft with synthetic bristles on one end that are used to remove plaque and food debris from its user's teeth. The bristle material is Nylon 612 or Polyamide 612. The Beam Brush collects brushing usage data based on the principle that the human body possesses the property of being a good capacitor, such that the human body has a detectable capacitance. This capacitance is transferrable through a thermoplastic material. The Beam Brush comprises a capacitive sensor, which is completely enclosed in the toothbrush body. The capacitive sensor detects that the Beam Brush is in use based on the capacitance introduced by the human body when the Beam Brush is utilized for its intended purpose. The Beam Brush wirelessly transmits the collected data using radio frequency transmission, more specifically Bluetooth® radio. The Bluetooth® standard defines the parameters for transmission of data via radio frequency including a transmitting frequency of 2.4 GHz. The Beam Brush is a Class 2 Bluetooth® device, which has a transmission range of about 30 feet and a maximum power of 2.5 mW. The data is received by a user's own mobile device that runs a software application (Beam App), which is of a minor level of concern. The Beam App is an accessory to the Beam Brush and allows the user to view his/her brushing usage data for the user's convenience and education. The Beam App, collection of data, and transmission of data are not intended for the diagnosis and treatment of disease or to affect the structure or function of the body. The Beam Brush's capacitive sensor and Bluetooth® radio are powered by a single AA alkaline battery that is replaceable. The Beam Brush also comprises a replaceable brush head that connects to the handle at the base of the neck.
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    K Number
    K102871
    Device Name
    SILVER CARE ANITBACTERIAL TOOTHBRUSH
    Manufacturer
    PIAVE SPAZZOLIFICIO S.P.A.
    Date Cleared
    2011-10-03

    (368 days)

    Product Code
    EFW
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    EFW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silver Care Antibacterial Toothbrush is intended for over-the-counter use as a toothbrush. The antibacterial agent maintains the cleanliness of the brush by preventing the growth of bacteria on and between the filaments after use. The Silver Care is effective against E. coll (ATCC 25922), Klebsiella pneumoniae (ATCC 13388), Streptococcus mutans (ATCC 35668), and Pseudomonas aeruginosa (ATCC 27853) at 24 hours of exposure under moist conditions.
    Device Description
    Not Found
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    K Number
    K073224
    Device Name
    ORAL-B SUB-BRAND MANUAL TOOTHBRUSH
    Manufacturer
    PROCTER & GAMBLE
    Date Cleared
    2008-02-06

    (83 days)

    Product Code
    EFW
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    EFW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To promote good oral hygiene including plaque removal and treating and preventing gingivitis.
    Device Description
    The Oral-B® toothbrush is a manual toothbrush comprised of a shaft with synthetic bristles at one end. The bristles are arranged in a pattern to achieve effective mechanical plaque removal. Some of the bristle tufts have a wear indicator function. These Indicator bristles are colored with FDA approved colorant, FD&C Blue No. 2.
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    K Number
    K021383
    Device Name
    ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
    Manufacturer
    AGION TECHNOLOGIES, LLC.
    Date Cleared
    2002-07-17

    (76 days)

    Product Code
    EFW
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    EFW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Zeodyne Toothbrush with AgION™ Antimicrobial is intended to remove adherent plaque and food debris from the teeth. The addition of the antimicrobial agent is to prevent the growth of bacteria on the toothbrush between brushings. The antimicrobial treatment is not intended to have any effect on the user.
    Device Description
    The Zeodyne Toothbrush with AgION antimicrobial is a manual toothbrush consisting of a shaft with synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth. The toothbrush contains an antimicrobial agent to prevent the growth of bacteria on the brush between uses, maintaining the cleanliness of the brush. The Zeodyne Toothbrush with AgION antimicrobial consists of a polymer based handle and either Nylon 6-12 or polybutylene terephthalate (PBT) bristles. The bristles contain 0.5% AgION antimicrobial.
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    K Number
    K020776
    Device Name
    MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
    Manufacturer
    CORONET GROUP NORTH AMERICA, LLC.
    Date Cleared
    2002-06-03

    (84 days)

    Product Code
    EFW
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    EFW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medoral Hygienic Toothbrush with DENTOSAN® Filaments is a toothbrush to remove plaque and debris from the teeth and prevent tooth decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on and between the bristles after and between uses.
    Device Description
    The Medoral Hygienic Toothbrush is a toothbrush with DENTOSAN® filaments. The DENTOSAN® filament is a nylon filament impregnated with an anti bacterial agent to prevent the growth of bacteria on and between the filaments after use of the toothbrush.
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    K Number
    K000290
    Device Name
    LAZERSMILE, LAZERWHITE
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Date Cleared
    2000-04-14

    (74 days)

    Product Code
    EFW
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    EFW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994144
    Device Name
    TOOTHBRUSH WASH
    Manufacturer
    CAL HUECH, INC.
    Date Cleared
    2000-03-02

    (86 days)

    Product Code
    EFW
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    EFW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended to be used as an accessory to cleaning a toothbrush.
    Device Description
    Not Found
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    K Number
    K992435
    Device Name
    BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER
    Manufacturer
    AZO ENTERPRISES
    Date Cleared
    1999-10-15

    (85 days)

    Product Code
    EFW
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    EFW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to clean and sanitize toothbrushes before and after normal oral use.
    Device Description
    Not Found
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    K Number
    K980995
    Device Name
    PLAQ-ATAQ-I
    Manufacturer
    ETHICARE
    Date Cleared
    1998-08-20

    (174 days)

    Product Code
    EFW
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    EFW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SEE ATTACHED DEVICE SAMPLE (WHEN AVAILABLE, BRISTLE SAMPLE WILL BE SUBMITTED UPON REQUEST. BLACK DOTS INDICATE LOCATION OF THE TOOTH BRUSH BRISTLES). OUR PERFORMANCE AND REFERENCE CLAIMS TO THE USE OF THE PLAQ-ATAQ-I ARE: - 1) USED AS A REGULAR TRADITIONAL AND CURRENTLY MARKETED TOOTH BRUSH (SEE ORAL B - CREST-COMPLETE - REACH - COLGATE PLUS - TOP CARE - ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ) - 2) OVER THE COUNTER DENTIFRICE. - 3) THE LIQUID SPRAY SYSTEM INCORPORATED IN THE TOOTH BRUSH BODY CAN BE EMPLOYED FOR THE VALUES THAT THE MULTI-JETS PROVIDE. - 4) THE PLAIN TAP WATER STREAM IS FINGER-TIP CONTROLLED BY AN EASY, HAND-HELD TURNING VALVE (SEE TELEDYNE WATER PIK(R) AND HYDRO-FLOU™ MODELS). - 5) THE LIQUID STREAM FLUSHES OUT LOOSE PLAQUE AND DEBRIS BETWEEN THE TEETH AND GUMS THAT THE TOOTH BRUSH CANNOT REACH.
    Device Description
    Not Found
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