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510(k) Data Aggregation

    K Number
    K181965
    Device Name
    Restore Toothpaste
    Manufacturer
    Dr. Collins, Inc.
    Date Cleared
    2019-06-13

    (325 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Restore Toothpaste

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

    Restore Toothpaste is a fluoride-free toothpaste intended for cleaning the tooth surface on a daily basis. The toothpaste is formulated to provide rapid and continual desensitization through mechanical occlusion of exposed dentinal tubule.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA clearance letter for "Restore Toothpaste" (K181965). It confirms the device is substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria. The letter refers to a "premarket notification" and states that the FDA "reviewed your Section 510(k) premarket notification," meaning the manufacturer submitted data, but the content of that data and the study details are not present in these pages.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document is solely an FDA clearance letter and does not contain the technical study details requested.

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