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510(k) Data Aggregation

    K Number
    K240508
    Device Name
    Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
    Manufacturer
    Laclede, Inc.
    Date Cleared
    2024-04-19

    (58 days)

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

    Laclede, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relieve symptoms of dry mouth, refresh, moisturize, soothes oral irritation, and lubricate oral dryness.
    Device Description
    Salivea Dry Mouth Moisturizing Gel are specially formulated artificial saliva which contain moisturizers, humectants and salivary enzymes that collectively have lubricating, moisturizing, soothing and refreshing properties to relieve and treat the symptoms of dry mouth. The Salivea Dry Mouth Moisturizing Gel is supplied in 1 oz tube and sample foil pack.
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    K Number
    K180680
    Device Name
    Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray
    Manufacturer
    Laclede, Inc.
    Date Cleared
    2018-10-11

    (210 days)

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

    Laclede, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relieve symptoms of dry mouth, refresh, moisturize, clean and sooth oral irritation, and oral dryness.
    Device Description
    Salivea Dry Mouth Mouthwash and Salivea Dry Mouth Mouthspray are specially formulated saliva substitute which contain moisturizers, humectants and salivary enzymes that collectively have lubricating, moisturizing, soothing and refreshing properties to relieve and treat the symptoms of dry mouth. The Salivea Dry Mouth MouthSpray is supplied in non-pressurized pump action spray white Polyethylene terephthalate bottle. The Salivea Dry Mouth Mouthwash is supplied in white Polyethylene terephthalate bottle.
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    K Number
    K162235
    Device Name
    LUVENA VAGINAL MOISTURIZER & LUBRICANT
    Manufacturer
    LACLEDE, INC.
    Date Cleared
    2017-03-24

    (227 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    LACLEDE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Luvena Vaginal Moisturizer and Lubricant is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms, but is not compatible with polyurethane condoms.
    Device Description
    Luvena Vaginal Moisturizer & Lubricant is non-sterile, translucent, non-staining, non-greasy, aqueous-based, cranberry-flavored gel and is packed in EVA/PE copolymer plastic applicator tube. Each application tube is single-use. It is for personal vaginal use as need for moisturizing and lubrication during intimate sexual activity. This device is not a contraceptive or spermicide, nor does it contain any such component. It is compatible with natural rubber latex and polyisoprene condoms, but is not compatible with polyurethane condoms as demonstrated in condom compatibility testing conducted according to ASTM D7661-10.
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    K Number
    K150841
    Device Name
    Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant
    Manufacturer
    LACLEDE, INC.
    Date Cleared
    2015-12-29

    (274 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    LACLEDE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms, but is not compatible with polyurethane condoms.
    Device Description
    Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubrican are non-sterile, translucent, non-greasy, aqueous thick liquid intended for use as a personal lubricant. Luvena Enhanced Moisturizer and Luvena Enhanced Persona Lubricant are packed in a plastic bottle. These devices are neither contraceptives nor spermicidals, nor do they contain any such component. They are compatible with latex and polyisoprene condoms and not compatible with polyurethane condoms as demonstrated in condom compatibility testing conducted according to the standards defined by ASTM D7661.
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    K Number
    K061331
    Device Name
    ORAL BALANCE LIQUID/ GEL
    Manufacturer
    LACLEDE, INC.
    Date Cleared
    2006-07-25

    (74 days)

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

    LACLEDE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Refreshing Gel and Liquid that quickly diminishes dry discomfort, mouth odors, and other symptoms of a Dry Mouth.
    Device Description
    Oral Balance is an artificial saliva substitute which contains moisturizers, amino acids, milk proteins that have lubricating and moistening properties, it also contains patented salivary enzymes. Product is supplied in 1.5 oz PI.T bottle and tube.
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