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510(k) Data Aggregation

    K Number
    K111107
    Device Name
    SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE
    Manufacturer
    NORITAKE CO., INC.
    Date Cleared
    2011-06-30

    (71 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE

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

    For use in prosthetic dentistry to create the porcelain exterior on a porcelain fused to metal (PFM) dental prosthesis.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a dental device, "Super Porcelain EX-3 Universal Opaque." It is a regulatory document from the FDA, not a study report. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria, device performance, or study details.

    The document primarily focuses on:

    • Device Name: Super Porcelain EX-3 Universal Opaque
    • Regulation Number: 21 CFR 872.6660
    • Regulation Name: Porcelain Powder for Clinical Use
    • Regulatory Class: II
    • Product Code: EIH
    • Indications for Use: "For use in prosthetic dentistry to create the porcelain exterior on a porcelain fused to metal (PFM) dental prosthesis."
    • Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

    None of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications is present in this regulatory correspondence.

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