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510(k) Data Aggregation

    K Number
    K171330
    Device Name
    Nanova Sealant
    Manufacturer
    Nanova Biomaterials Inc
    Date Cleared
    2017-09-08

    (126 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Nanova Sealant

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

    Nanova Sealant is indicated for use as a pit and fissure sealant

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Nanova™ Sealant, a pit and fissure sealant. It confirms that the device has been found substantially equivalent to a predicate device.

    However, the provided text does NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    The document is a regulatory communication from the FDA, and while it confirms the device can be legally marketed, it does not detail the technical performance studies that would typically be included in a 510(k) submission to demonstrate substantial equivalence. Such performance data would be in the original 510(k) submission (K171330), not in the clearance letter itself.

    Therefore, I cannot provide the requested information from the given text.

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