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510(k) Data Aggregation

    K Number
    K992854
    Device Name
    ARTIFICIAL TEETH (ACRYLIC TEETH)
    Manufacturer
    MASTERDENT LTDA.
    Date Cleared
    2000-02-07

    (167 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ACRYLIC TEEHT ARE USE FOR MAKING, FULL AND PARTIAL DENTURES. THE ACRYLIC TEEHT ARE MOUNTED ON A APPLIANCE,MADE OF DENTAL ACRYLIC. ONCE THAT APPLIANCE IS MADE IS FITTED IN TO PATIENT MOUTH THIS APPLIANCE IS REMOVABLE ,IS NOT IMPLANTED.

    Device Description

    Artificial Teeth (Acrylic Teeth)

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for artificial teeth (acrylic teeth). It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the given input. The document is regulatory approval, not a scientific study report.

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