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510(k) Data Aggregation

    K Number
    K201785
    Device Name
    EPIEN Dental Cleanser
    Manufacturer
    EPIEN Medical, Inc.
    Date Cleared
    2021-09-09

    (436 days)

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

    EPIEN Dental Cleanser

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

    EPIEN DENTAL CLEANSER is indicated for the following uses:

    1. Caries Restoration Procedures - EPIEN DENTAL CLEANSER is indicated for use as an adjunctive rinse of exposed dentin surfaces in cavity preparations to assist in the removal of contaminated debris and smear-layer.

    2. Chronic Periodontitis Treatment Procedures - EPIEN DENTAL CLEANSER is indicated for use as an adjunctive rinse of tooth root surfaces during periodontal debridement procedures (scaling and root planing) to help with the removal of contaminated debris from the sulcus.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria.

    The document is a 510(k) clearance letter from the FDA to EPIEN Medical, Inc. for their device, the "EPIEN Dental Cleanser." It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory obligations for the manufacturer. It specifies the "Indications for Use" for the dental cleanser.

    Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, ground truth methods, or MRMC study details, as these are not present in the provided text.

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