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510(k) Data Aggregation

    K Number
    K141839
    Device Name
    PREMIER ETCH
    Manufacturer
    PREMIER DENTAL PRODUCTS CO.
    Date Cleared
    2014-11-17

    (132 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K213093
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Premier Etch is a prescription- only, 37% phosphoric acid etchant in a gel form that is used by the dental professional for etching dentin or enamel prior to tooth restoration.

    Device Description

    Premier Etch is a prescription- only, 37% phosphoric acid etchant in a gel form.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. It is a 510(k) clearance letter from the FDA for a dental etching product, "Premier Etch," confirming its substantial equivalence to legally marketed predicate devices. The letter primarily addresses regulatory compliance and device classification.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.

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