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510(k) Data Aggregation

    K Number
    K061322
    Device Name
    PORCELAIN PRIMER
    Manufacturer
    J. MORITA USA, INC.
    Date Cleared
    2006-06-02

    (22 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K091300
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Porcelain primer is an agent for enhancing bonds to porcelain, ceramic, procured composites and Surfaces of non-precious metals. When prepared with a thin layer of Porcelain Primer, the areas are ready for bonding with acrylic resins. Suitable acrylic resins are bonding resins, flowable composites or composite to for to rooms. Bunaole actylic Testins are oonding resins, flowable work work.

    Device Description

    Porcelain Primer

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Porcelain Primer." It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot provide the requested information. The document does not describe:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number or qualifications of experts for ground truth establishment.
    4. Adjudication methods.
    5. MRMC comparative effectiveness study results.
    6. Standalone algorithmic performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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