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510(k) Data Aggregation

    K Number
    K233768
    Device Name
    Papacarie Duo
    Manufacturer
    Elevate Oral Care
    Date Cleared
    2024-07-18

    (237 days)

    Product Code
    LBH, KLE
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    Elevate Oral Care

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Papacarie Duo is a gel cleanser intended to clean the interior of a prepared cavity of a tooth prior to self-etch bonding procedures.
    Device Description
    Papacarie Duo is a light blue colored gel cleanser dispensed from a prefilled, multi-use syringe storage system to a mixing pad, then applied to the interior of a prepared tooth cavity by dental professionals using a flocked tip brush or micro brush (not included). The tooth cavity is rinsed with water 60 seconds after application and prior to application of self-etch bonding material. The formula has a light blue color for easier visualization when it is applied on tooth surfaces. For single application prior to self-etch bonding procedure.
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    K Number
    K222323
    Device Name
    Black Diamond
    Manufacturer
    Elevate Oral Care, LLC
    Date Cleared
    2023-06-23

    (325 days)

    Product Code
    PHR
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    Elevate Oral Care, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Black Diamond is intended as Treatment of Dental Hypersensitivity. For use in adults over the age of 21.
    Device Description
    Black Diamond is a two-part liquid intended as a treatment for dentin hypersensitivity, for use in adults over the age of 21. The product does not need light cured and will provide occlusion of dentinal tubules preventing or reducing dentin hypersensitivity. The formula has two liquid steps, each provided in an individual dropper bottle. A drop of each product is placed in a mixing well/dappen dish and applied sequentially to the tooth using a standard flock tip applicator bush such as a microbrush. The mixing pad, and applicator may or may not be included in the product package. These are standard items in dental offices and numerous types of each will work.
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    K Number
    K150074
    Device Name
    Elevate Moisturizing Spray
    Manufacturer
    ELEVATE ORAL CARE
    Date Cleared
    2015-06-19

    (156 days)

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

    ELEVATE ORAL CARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Elevate Moisturizing Spray is indicated to provide comfort for individuals suffering from dry mouth. It is recommended to be used by people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth. - Elevate Moisturizing Spray is indicated for rapid relief of dry mouth symptoms, to provide a protective coating inside the mouth and to help control bad breath. - A mouth spray that quickly reduces mouth discomfort, oral malodor and other symptoms of dry mouth.
    Device Description
    Elevate Moisturizing Spray is a viscous liquid dispensed from a spray bottle into the mouth. The spray will coat the inside of the mouth for a period of time and create relief from dry mouth symptoms in those who suffer oral malodor, discomfort, difficulties eating or speaking from dry mouth complications.
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    K Number
    K131376
    Device Name
    SMARTCOAT 2.5% NAF VARNISH
    Manufacturer
    ELEVATE ORAL CARE
    Date Cleared
    2013-08-27

    (105 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELEVATE ORAL CARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SmartCoat 2.5% NaF Varnish is intended for use on sensitive teeth, over exposed dentin . and root surface sensitivity, and under temporary restorations or cements where post operative sensitivity is of concern. . Rapid Desensitizer . Provides rapid relief from sensitive teeth due hypersensitivity
    Device Description
    SmartCoat 2.5% NaF Varnish is classified as a Cavity Varnish (21 CFR 872.3260) because it is a device that provides relief from tooth surface hypersensitivity when applied to dentin surfaces by forming a film that facilitates occlusion of compromised surfaces including open dentinal tubules. SmartCoat is a topically applied, flavored cavity varnish containing sodium fluoride in a shellac resin based preparation. The varnish is an insoluble viscous liquid that dries once applied to the teeth to form a surface film. The packaging provides an accurate dosing and uniform dispensing mechanism for consistent product mixing and delivery.
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