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510(k) Data Aggregation

    K Number
    K250390
    Device Name
    CloSYS® Dry Mouth Sensitive Mouth Rinse
    Manufacturer
    Rowpar Pharmaceuticals Inc.
    Date Cleared
    2025-05-19

    (97 days)

    Product Code
    LFD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relieves the symptom and discomfort of dry mouth, refreshes, moisturizes/hydrates, and lubricates oral dryness.
    Device Description
    CloSYS® Dry Mouth Sensitive Mouth Rinse is an oral rinse designed to alleviate the symptoms of dry mouth for home use. The formulation includes water, humectants/ moisturizers, flavors, sweeteners, as well as ingredients with lubricating, soothing, and refreshing properties. The product is a ready-to-use, non-sterile, semi-viscous clear liquid, packaged in 16.0 FL OZ white High-Density Polyethylene (HDPE) bottles within a carton. Accelerated stability testing of the finished product supports a shelf life of 2 years. The rinse is formulated to have similar properties as predicate product Biotene Dry Mouth Oral Rinse Fresh Mint, which is a medical device 510(k) Number K123731 and the reference device Hydris™ Oral Rinse cleared under K163029. CloSYS® Dry Mouth Sensitive Mouth Rinse will be available in 16 fl oz (473 mL) PET bottles in a carton.
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    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?
    Product Code :

    LFD

    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
    K234015
    Device Name
    Caphosol® Artifical Saliva (32 doses sachet box)
    Manufacturer
    EUSA Pharma (UK) Limited
    Date Cleared
    2024-03-11

    (83 days)

    Product Code
    LFD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Caphosol® is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the conditions are temporary or permanent. Caphosol® is also indicated as an adjunct to standard oral care in treating mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain. Caphosol® may be used for relief of dryness of the oral mucosa when hyposalivation results from the following: surgery, radiotherapy near the salivary glands, chemotherapy, infection or dysfunction of the salivary glands; inflammation of the mouth or throat; fever; emotional factors such as fear or anxiety; obstruction of the salivary ducts; Sjogren's syndrome; and Bell's Palsy. Caphosol® is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholinergic agents that suppress salivary secretion. It may be used as part of an oral hygiene program for patients with dry mouth. Caphosol® provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste and to relieve offensive nasal discharge and crusting.
    Device Description
    Caphosol® is an electrolyte solution resembling human saliva, designed in part to replace the normal ionic and pH balance in the oral cavity. It is intended as a mouth rinse to moisten, lubricate, and clean the oral cavity including the mucosa of the mouth, tongue, and throat. Caphosol® maintains moistness in the oral cavity. It relieves diffuse dryness and fissuring of the: oral mucosa, as well as painful tongue conditions due to hyposalivation. Patients having this condition are also prone to dental caries and candidal infections. Caphosol® is a partial substitute for natural saliva. Caphosol® facilitates chewing and speaking; loosens tough mucus; prevent mucous membranes from sticking together, helps remove nasal crust and relieve nasal soreness; improves adherence of dentures, and also relieves bad taste. Caphosol® is an adjunct to standard oral care for treating mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration · of pain. Caphosol® is a preparation comprising two separately packaged aqueous solutions, a phosphate solution (Caphosol® A) and a calcium solution (Caphosol® B) which when both sachet solutions are combined in equal volumes form a solution supersaturated with respect to both calcium and phosphate ions.
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    K Number
    K231205
    Device Name
    GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
    Manufacturer
    GuruNanda LLC
    Date Cleared
    2023-08-22

    (117 days)

    Product Code
    LFD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are intended to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation, and lubricate oral dryness.
    Device Description
    The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are specifically formulated as an artificial saliva substitute with water, moisturizers, humectants, sweeteners, and flavors that collectively have lubricating, moisturizing, and refreshing properties to help relieve and manage the symptoms of dry mouth (xerostomia).
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    K Number
    K202689
    Device Name
    Dentilube Spray
    Manufacturer
    Oxy2plus, LLC
    Date Cleared
    2021-09-03

    (353 days)

    Product Code
    LFD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dentilube dry mouth spray is indicated for the symptomatic relief from the effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors and other oral symptoms associated with dry mouth.
    Device Description
    Dentilube dry mouth spray is a viscous pink electrolyte-containing solution that is designed to mimic the compositions and actions of saliva to moisturize, and refresh the mouth. It provides a lubricating and moisturizing coating inside the mouth, thereby relieving symptoms of dry mouth. The product is supplied in 50mL or 100 mL PET bottles.
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    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?
    Product Code :

    LFD

    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?
    Product Code :

    LFD

    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
    K181839
    Device Name
    CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
    Manufacturer
    OraLabs, Inc.
    Date Cleared
    2019-11-21

    (498 days)

    Product Code
    LFD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use as needed for instant relief. OraLabs Dry Mouth Pocket Spray helps maintain the oral environment and helps provide protection against dry mouth symptoms.
    Device Description
    OraLabs Dry Mouth Pocket Spray is a specially formulated water soluble artificial saliva substitute with a pH between 5.20 to 7.20 for use at home in the oral cavity. OraLabs manufactures the products in a 0.25 FL OZ polyethylene bottle with a non-aerosol pump. The formula contains water, moisturizers, thickeners/binders, buffers, flavor, sweetener and preservatives. The combination of ingredients collectively provides moisturizing, lubricating, soothing, and refreshing properties.
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    K Number
    K190144
    Device Name
    MucoPEG
    Manufacturer
    SunBio, Inc.
    Date Cleared
    2019-11-05

    (280 days)

    Product Code
    LFD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MucoPEG™ is indicated to relieve the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation, and lubricate oral dryness.
    Device Description
    MucoPEG™ is an artificial saliva to relieve xerostomia symptoms and discomfort. The main ingredient of MucoPEG™ is a polyethylene glycol (PEG) derivative. The additives to MucoPEG™ are mint (for flavor) and sodium bicarbonate (for pH maintenance when dissolved in water). MucoPEG™ is formulated as a powder and packaged in a single-use packet.
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    K Number
    K181194
    Device Name
    SmartMouth DryMouth Oral Rinse
    Manufacturer
    Triumph Pharmaceuticals, Inc.
    Date Cleared
    2019-02-15

    (287 days)

    Product Code
    LFD
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provides relief of the symptoms and discomfort of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation and lubricates oral dryness. Freshens breath.
    Device Description
    SmartMouth® DryMouth Oral Rinse is a specially formulated water soluble artificial saliva with for use at home in the oral cavity. It is formulated with water, humectants/moisturizers, including two moisture-rich humectants that are plant based, thickeners/binders, buffers, sweeteners, flavor, and colorant that collectively have moisturizing, soothing, and refreshing properties. The device is provided ready to use as a non-sterile, two-part semi-viscous green colored liquid packaged in white polyethylene terephthalate (PET) bottles with a clear polypropylene cap that present the liquid out of the polypropylene spout.
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