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510(k) Data Aggregation

    K Number
    K970589
    Device Name
    MICROETCHER AP
    Manufacturer
    DANVILLE ENGINEERING, INC.
    Date Cleared
    1997-09-17

    (211 days)

    Product Code
    KOJ
    Regulation Number
    872.6080
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MICROETCHER AP

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

    Cutting and preparation of tooth structure, both enamel and dentin for all classes of cavity preparations. Removal of composite resin restorations. Surface roughening of enamel,dentin, and metal dental structures prior to adhesive resin bonding.

    Device Description

    Microetcher AP

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called "Microetcher Ap" and contains an FDA determination of substantial equivalence. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested table and study details. The document is an FDA clearance letter, not a study report.

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