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510(k) Data Aggregation

    K Number
    K983106

    Validate with FDA (Live)

    Device Name
    1ST IMPRESSION
    Manufacturer
    DEN-MAT CORP.
    Date Cleared
    1999-02-09

    (158 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Utilized by a dental Heath-care profession.) for making high-definition dental impressions. as port of dental prosthesis procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details, or ground truth establishment. The document appears to be a 510(k) premarket notification letter from the FDA, discussing the substantial equivalence of a dental impression device, but it lacks the specific technical details you're looking for.

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