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    K Number
    K112597
    Device Name
    SEITY 37% PHOSPHORIC ACID ETCHANT GEL
    Manufacturer
    MYCONE DENTAL SUPPLY CO., INC.
    Date Cleared
    2011-12-07

    (91 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SEITY 37% PHOSPHORIC ACID ETCHANT GEL

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

    A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.

    Device Description

    Seity 37% Phosphoric Acid Etchant Gel

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental etchant gel. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    This document describes a dental etchant gel, which is a chemical product, not a software device or an AI/ML-based medical device. Therefore, the questions regarding acceptance criteria, study details, sample sizes, ground truth, and AI/ML performance are not applicable to the information provided in this document.

    The letter focuses on regulatory approval based on substantial equivalence to existing products, rather than performance studies as would be required for novel medical devices or AI/ML systems. No information about a study proving the device meets acceptance criteria in the context of an AI/ML device is present.

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