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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    OraLabs, Inc.

    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
    K113326
    Device Name
    ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD
    Manufacturer
    ORALABS, INC.
    Date Cleared
    2012-06-27

    (230 days)

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

    ORALABS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oral B plus Scope Outlast Nighttime Dental Guard is an Over-the-Counter dental guard indicated for the protection against bruxism - the nighttime clenching and grinding of the teeth. It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated teeth grinding.
    Device Description
    a mouthguard constructed of a propylene-based elastomer. The target area is the oral cavity of individuals that suffer from bruxism, nighttime teeth grinding. The device works by molding the thermoplastic resin to the individual's mouth. The thermoplastic resin can be molded after submerged in boiling water via the microwave. The molded thermoplastic resin is worn at to reduce damage to the teeth and to prevent the noise associated teeth grinding. OraLabs Oral-B plus Scope Outlast Nighttime Dental Guard is intended for individuals age 18 and older. Thermoplastic can be molded to fit all sizes.
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