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510(k) Data Aggregation

    K Number
    K203567
    Device Name
    Oral-B Dry Mouth Oral Rinse
    Manufacturer
    The Procter & Gamble Company
    Date Cleared
    2021-04-05

    (119 days)

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

    **The Procter **& Gamble Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relieves the symptoms and discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation and lubricates oral dryness. Provides long lasting relief for up to 6 hours.
    Device Description
    The Oral-B® Dry Mouth Oral Rinse is a non-sterile clear liquid formulated as an artificial saliva (LFD) intended to be marketed over the counter for at-home use. The artificial saliva for dry mouth is formulated with gel film forming polysaccharides, sodium hyaluronate, which possess lubricating and moisturizing properties. Oral-B® Dry Mouth Oral Rinse also contains water, moisturizers/humectants, thickener, surfactant, pH adjusters, preservative, sweetener and flavor that collectively form the device formulated at a pH of 6 and designed to help relieve and manage the symptoms of dry mouth. A list of device components can be found in Table 5-1. None of the constituents used in the device are novel materials not previously used in a legally marketed US-medical device). The device is intended to be used for 30 seconds each use, up to five times daily for consumers 12 years or older. Oral-B® Dry Mouth Oral Rinse is supplied in a 16-fluid ounce white Polyethylene Terephthalate (PET) bottle, with a white polypropylene closure and a clear polypropylene dosing cup.
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    K Number
    K201277
    Device Name
    Oral-B Dry Mouth Oral Rinse
    Manufacturer
    The Procter & Gamble Company
    Date Cleared
    2020-09-02

    (112 days)

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

    **The Procter **& Gamble Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relieves the symptoms and discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation and lubricates oral dryness. Provides long lasting relief for up to 4 hours.
    Device Description
    The Oral-B® Dry Mouth Oral Rinse is a non-sterile clear liquid formulated as an artificial saliva (LFD) intended to be marketed over the counter for at-home use. The artificial saliva for dry mouth is formulated with gel film forming polysaccharides, sodium hyaluronate, which possess lubricating and moisturizing properties. Oral-B® Dry Mouth Oral Rinse also contains water, moisturizers/humectants, thickener, surfactant, pH adjusters, preservative, sweetener and flavor that collectively form the device formulated at a pH of 6 and designed to help relieve and manage the symptoms of dry mouth. A list of device components can be found in Table 5-1. None of the constituents used in the device are novel materials not previously used in a legally marketed US-medical device). The device is intended to be used for 30 seconds each use, up to five times daily for consumers 12 years or older. Oral-B® Dry Mouth Oral Rinse is supplied in a 16-fluid ounce white Polyethylene Terephthalate (PET) bottle, with a white polypropylene closure and a clear polypropylene dosing cup.
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    K Number
    K200881
    Device Name
    Oral-B iO Test Drive Power Brush Trial Program Kit
    Manufacturer
    The Procter & Gamble Company
    Date Cleared
    2020-08-27

    (147 days)

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

    **The Procter **& Gamble Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oral-B® iO Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene. The Oral-B® iO Test Drive Power Brush Trial Program Kit is indicated for use under the direct supervision of a dental professional, exclusively at conventions (e.g. professional, scientific, trade shows), as part of the Oral-B® iO Test Drive Power Brush Trial Program.
    Device Description
    The Oral-B® iO Test Drive Power Brush Trial Program for conventions (e.g. professional, scientific, trade shows), is designed to introduce convention delegates to the newest, most advanced Oral-B electric rechargeable toothbrush as a means to promote good oral hygiene. The program kit contains a power toothbrush consisting of a rechargeable handle, a charger, replacement brush heads, and instructions for the proper use and care of the device. The program kit also contains plastic dental sheaths to prevent soiling and therefore allowing for easier cleaning of the multi-user handle. The sheath is manufactured by TIDI Products, LLC, is provided to Procter & Gamble as a finished, packaged non-sterile device (K132953) for inclusion in the program kit as an accessory. Detailed instructions for cleaning and disinfection of the reusable handle are also included. The program kit is indicated for use as an introductory trial, exclusively within the confines of a convention (e.g. professional, scientific, trade shows), under the direct supervision of a dental professional as part of the Oral-B® iO Test Drive Power Brush Trial Program.
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    K Number
    K133244
    Device Name
    TAMPAX M PLASTIC TAMPONS, UNSCENTED
    Manufacturer
    THE PROCTER & GAMBLE COMPANY
    Date Cleared
    2014-01-09

    (79 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    **THE PROCTER **& GAMBLE COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TAMPAX® M Plastic Applicator Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.
    Device Description
    Unscented menstrual tampons for absorption of menstrual fluid. The tampon is a conventional design consisting of an absorbent pledget, an overwrap, a withdrawal cord and an applicator. The materials of construction are cotton, rayon, polypropylene and polyester. The device functions by absorbing menstrual fluid after being inserted into the vagina.
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    K Number
    K113699
    Device Name
    TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED
    Manufacturer
    THE PROCTER & GAMBLE COMPANY
    Date Cleared
    2012-01-12

    (27 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    **THE PROCTER **& GAMBLE COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TAMPAX® V Plastic Applicator Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.
    Device Description
    Unscented menstrual tampons for absorption of menstrual fluid. The tampon is a conventional design consisting of an absorbent pledget, an overwrap, a withdrawal cord and an applicator. The materials of construction are cotton, rayon, polypropylene and polyester. The device functions by absorbing menstrual fluid after being inserted into the vagina.
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    K Number
    K110669
    Device Name
    TAMPAX C PLASTIC TAMPONS, UNSCENTED
    Manufacturer
    THE PROCTER & GAMBLE CO.
    Date Cleared
    2011-06-02

    (85 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    **THE PROCTER **& GAMBLE CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TAMPAX® C Plastic™ Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.
    Device Description
    Unscented menstrual tampons for absorption of menstrual fluid
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    K Number
    K091419
    Device Name
    VICKS POWERSHOT DRY THROAT & MOUTH RELIEF
    Manufacturer
    THE PROCTER & GAMBLE CO.
    Date Cleared
    2009-08-28

    (107 days)

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

    **THE PROCTER **& GAMBLE CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vicks Powershot Dry Throat and Mouth Relief Spray - For immediate and effective relief of dry throat and dry mouth by coating, moistening and lubricating. Vicks Powershot Dry Throat and Mouth Relief Liquid – For immediate and effective relief of dry throat and dry mouth by coating, moistening and lubricating.
    Device Description
    Vicks Powershot Dry Throat and Mouth Relief is available for application cither as a spray or as a bulk liquid, the latter using a dispensing cup. It is a device intended for over-the-counter (OTC) consumer use. The device delivered as a spray form will be packaged in a 1.01 Fl.Oz. (30 mL) polyethylene tercphthalate (PET) plastic bottle and will be dispensed from the bottle via a positive displacement pump. The device delivered using a dispensing cup will be packaged in a 6 Fl.Oz (177mL) PET plastic bottle and will be dispensed via a polypropylene dispensing cup. The device is a clear liquid and contains polymers, including carboxymethylcellulose (CMC) that is known to coat and lubricate, as well as components that function as humectants and solvents. The device is preserved and lightly flavored for improved taste. Upon application the device coats and lubricates the mucus membrane of the mouth and oropharynx thereby providing immediate relief of dryness. The device thus functions as an artificial saliva device.
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