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510(k) Data Aggregation

    K Number
    K982913
    Device Name
    ZINFOS ZINC PHOSPHATE CEMENT
    Manufacturer
    SCIENTIFIC PHARMACEUTICALS, INC.
    Date Cleared
    1998-10-19

    (61 days)

    Product Code
    EMA,DAT
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ZINFOS ZINC PHOSPHATE CEMENT

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

    For permanent cementation of Crowns and bridges on non-vital teeth and on vital teeth where the use of Conventional Zinc Phosphate Cements is judged appropriate.

    Device Description

    ZinFos Zinc Phosphate Cement

    AI/ML Overview

    The provided document is a 510(k) clearance letter for a medical device called "ZinFos Zinc Phosphate Cement." This document is not a study report and therefore does not contain the information requested in the prompt.

    The prompt asks for details about acceptance criteria and a study proving device performance, typically found in a clinical or performance assessment report for a device, especially for those involving AI or diagnostic capabilities. The ZinFos Zinc Phosphate Cement is a traditional dental cement, and its regulatory clearance would be based on substantial equivalence to predicate devices, rather than a performance study as described in the prompt's questions.

    Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study results, or ground truth details from the given text.

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