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510(k) Data Aggregation

    K Number
    K023751
    Device Name
    EXAJET
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2003-01-22

    (75 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EXAJET

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

    To se used as impression materials for taking intraoral impressions in a dual phase impre: sion technique.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that the device meets such criteria. The document is a 510(k) clearance letter from the FDA for a dental impression material named "EXA Jet," stating that the device is substantially equivalent to a legally marketed predicate device.

    The letter does not include details regarding:

    • A table of acceptance criteria or reported device performance.
    • Sample sizes or data provenance for any test sets.
    • The number or qualifications of experts for ground truth establishment.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.
    • The type of ground truth used.
    • Sample size for training sets.
    • How ground truth for training sets was established.

    The document is purely an FDA clearance notice based on substantial equivalence, and therefore, an actual performance study against specific acceptance criteria is not detailed within this text.

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