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    K Number
    K040473
    Device Name
    ORAVIVE TOOTH REVITALIZING PASTE
    Manufacturer
    NOVAMIN TECHNOLOGY, INC.
    Date Cleared
    2004-03-10

    (15 days)

    Product Code
    LBH,NRE
    Regulation Number
    872.3260
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K024343
    Why did this record match?
    Device Name :

    ORAVIVE TOOTH REVITALIZING PASTE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Oravive™ is a fluoride-free toothpaste product intended for cleaning the tooth surface on a daily basis. Clinical studies have shown that Oravive™ also provides relief from tooth sensitivity due to cold, heat, acids, sweets, or contact by the occlusion of dentin tubules.

    Device Description

    Oravive™ is a daily-use, fluoride-free toothpaste device that incorporates NovaMin® as its active ingredient. The non-aqueous formulation is designed to clean your teeth as well as give your whole mouth a fresh feeling we call REVITALIZING! Oravive™ is also designed to physically occlude dentin tubules for the management of sensitive teeth. NovaMin® (calcium sodium phosphossilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aquoous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state formal "acceptance criteria" for clinical performance in a quantifiable, pre-defined manner. Instead, it describes findings that support the device's efficacy and safety compared to controls and a predicate device. The performance claims are primarily related to reduction in tooth sensitivity and abrasivity.

    Acceptance Criteria (Implied)Reported Device Performance
    Safety: BiocompatibilityNo evidence of hazardous effects if used as directed.
    Occlusion Efficacy (in vitro): Significant tubule occlusion compared to controlsOravive™ occludes a statistically significant number of tubules compared to controls.
    Abrasivity: RDA value
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