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510(k) Data Aggregation

    K Number
    K061351
    Device Name
    ORAL-B SONIC COMPLETE
    Manufacturer
    BRAUN GMBH
    Date Cleared
    2006-06-05

    (21 days)

    Product Code
    JEQ
    Regulation Number
    872.6865
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAUN GMBH

    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
    Oral-B® Sonic Complete™ is a rechargeable electric toothbrush comprised of a charging unit and a rechargeable power handle. The rechargeable power unit is inductively charged and therefore electrically safe in accordance with the Second Edition of the standard for Personal Hygiene and Health Care appliances, UL 1431. The Oral-B® Sonic Complete™ electric toothbrush has a vibrating brush head that moves with a side-to-side movement. The brush head is designed to facilitate deeper penetration of interdental areas. The brush head moves side along the axis of the brush head at 260 Hz at an unloaded angle of ± 5 degrees. The brush head has no moving parts and is similar to a manual brush. The Oral-B® Sonic Complete™ has a longitudinal brush head with a length of 22 mm and a width of a 9mm. The tufts are angled in 3 directions. The inner row with oval tufts and the outer rows are angled in opposite directions at an angle of 7.5 degrees. In addition, the outer rows are angled outwards for improved gumline cleaning at an angle of 5 degrees. The bristles are standard nylon filaments with a diameter of 6 and 6.5 mil. Two rows of bristles are longer and form a power tip for improved interproximal cleaning. These power tips have a wear indicator function and are colored with the FDA approved colorant FD&C blue No.2. The bristle material is Polyamid or PA6.12. The Oral-B® Sonic Complete™ features a Pressure Control to help avoid possible gingival damage by users who apply excessive pressure during brushing; the drive system and the soft bristles are designed so that the bristle tip movement dramatically decreases to almost zero at applied loads above 2 N. It also features a Professional Timer and a Push-Push switch. The Professional Timer automatically interrupts the brushing motion briefly with a short stuttering sound every 30 seconds to remind the user to move to another quadrant of the mouth, so that each quadrant is brushed equally. At the moment we only have a "stuttering timer" as described, however there soon will be a version sounding a "beeping noise" after 2 minutes brushing time, Oral-B® Sonic Complete™ offers customized brushing modes for complete mouth care. The basic godel offers two modes and the deluxe model offers three modes controlled by the Push switch: Clears for a complete cleaning of your teeth and gums, Soft: for the gentle care of your tongue and other sensitive areas, and Massage: (deluxe model only) for a gentle stimulation of gums. The toothbrush features a round handle, with anti-slip characteristics for better control in wet conditions.
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    K Number
    K061199
    Device Name
    ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES
    Manufacturer
    BRAUN GMBH
    Date Cleared
    2006-05-31

    (33 days)

    Product Code
    JEQ
    Regulation Number
    872.6865
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAUN GMBH

    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
    Oral-B® ProfessionalCare/Oral-B® AdvancePower is a rechargeable electric toothbrush comprised of a charging unit and a rechargeable power unit. The rechargeable power unit is inductively charged and therefore electrically safe in accordance with the Second Edition of the standard for Personal Hygiene and Health Care appliances, UL 1431. The Oral-B® ProfessionalCare/Oral-B® AdvancePower electric toothbrush has an oscillating/rotating technology, a small round brush head that aids tooth-to-tooth cleaning. The brush head is designed to facilitate deeper penetration of interdental areas. The action of the brush head has an oscillation range frequency between 63 to 73 Hz with a vibration frequency of 340 Hz (3800 strokes per minute) and an oscillating range angle of 42° to 60° depending on the toothbrush model. The brush head design is a small circular brush head and features an arrangement of flagged bristles and power tips. The power tips have tufts of longer bristles on either side of the brush head in the outer ring. These power tips have a wear indicator function and are colored with the FDA approved colorant FD&C blue No.2. The flagged bristle tufts have tetralocular filaments and are designed to increase the brushing action on tooth surfaces. The bristle material is Polyamid or PA6.12. The toothbrush features a round handle with anti-slip characteristics for better control in wet conditions and offers a variable range of speeds to best meet individual needs. Oral-B® Professional Care™ Series/Oral-B® AdvancePower™ Series products are rechargeable battery operated toothbrushes. The toothbrush handles are inductively charged so there is no electrical connection between the charger and handle. All electrical components are housed within thermoplastic enclosures and the product is provided with a Listed 1flexible supply cord terminating in a parallel blade attachment plug for connection to a nominal 100-120 V, 50-60 Hz supply source.
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    K Number
    K060006
    Device Name
    BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER
    Manufacturer
    BRAUN GMBH
    Date Cleared
    2006-01-31

    (28 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAUN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Braun ThermoScan IRT 2000 infrared ear thermometer is indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment.
    Device Description
    Braun Thermoscan infrared ear thermometers are hand-held, battery-powered devices that are intended to be used for the intermittent measurement and monitoring of human body temperature of people of all ages. They measure infrared energy that is emitted from the tympanic membrane and surrounding tissue.
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    K Number
    K031928
    Device Name
    BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT)
    Manufacturer
    BRAUN GMBH
    Date Cleared
    2003-10-24

    (123 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAUN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PRO 4000 series: The Braun Thermoscan PRO 4000 series infrared ear thermometers are indicated for the intermittent measurement and monitoring of human body temperature by professionals in a professional use environment. IRT 4000 series: The Braun Thermoscan IRT 4000 series infrared ear thermometers are indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment.
    Device Description
    Braun Thermoscan infrared ear thermometers are hand-held, battery-powered devices that are intended to be used for the intermittent measurement and monitoring of human body temperature of people of all ages. They measure infrared enerqy that is emitted from the tympanic membrane and surrounding tissue.
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    K Number
    K012035
    Device Name
    BRAUN PRECISION SENSOR PRO, MODEL BP 2590
    Manufacturer
    BRAUN GMBH
    Date Cleared
    2001-07-27

    (28 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAUN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Braun PrecisionSensor Pro (BP2590) wrist blood pressure monitor is indicated for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults, in a professional environment. Use may be initiated as part of a hypertension screening, monitoring, and/or management program supervised by a healthcare provider.
    Device Description
    The PrecisionSensor Pro is a non-invasive wrist blood pressure monitor that measures and displays systolic and diastolic blood pressure, and pulse rate. The values are ascertained by the oscillometric method.
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    K Number
    K003732
    Device Name
    BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES
    Manufacturer
    BRAUN GMBH
    Date Cleared
    2001-05-16

    (163 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAUN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992468
    Device Name
    BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER
    Manufacturer
    BRAUN GMBH
    Date Cleared
    1999-10-20

    (89 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAUN GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Braun ThermoScan® PRO 3000 Infrared Thermometer is intended for the intermittent measurement and monitoring of human body temperature, by medical professionals. It is intended for use on people of all ages.
    Device Description
    The Braun ThermoScan® PRO 3000 Infrared Thermometer is a hand held instrument that measures temperature through the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.
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