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510(k) Data Aggregation

    K Number
    K011706
    Device Name
    FLEXICAST PRIME
    Manufacturer
    AMERICAN DENT-ALL, INC.
    Date Cleared
    2001-08-06

    (63 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FLEXICAST PRIME

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

    Flexicast Prime ( Partial Denture Dental Casting Alloy ) is for use in dental laboratories, suitable for preparation of removable dental appliances.

    Device Description

    Flexicast Prime ( Partial Denture Dental Casting Alloy )

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a dental casting alloy named "Flexicast Prime."

    It confirms the device's substantial equivalence to a predicate device and its regulatory classification. However, it does not include:

    • A table of acceptance criteria or reported device performance.
    • Details about a study, sample sizes, data provenance, expert qualifications, or ground truth establishment.
    • Information on MRMC studies or standalone algorithm performance.

    The letter explicitly states that it is a response to the premarket notification submission and that "The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market." This type of document typically does not elaborate on the specific performance studies that were submitted to demonstrate substantial equivalence, but rather notifies the applicant of the FDA's decision.

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