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510(k) Data Aggregation

    K Number
    K071201
    Device Name
    ZEO CE LIGHT & ZEO QUICK PORCELAIN
    Manufacturer
    XPDENT CORP.
    Date Cleared
    2007-07-30

    (91 days)

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

    ZEO CE LIGHT & ZEO QUICK PORCELAIN

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

    Porcelain fused to metal for dental use.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) summary for a dental porcelain device. It is a regulatory document from the FDA outlining the substantial equivalence determination for "Zeo CE Light and Zeo Quick Porcelain."

    This document does not contain information regarding:

    • Acceptance criteria and reported device performance.
    • Sample sizes, data provenance, or expert qualifications for a study.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.
    • Types of ground truth used.
    • Training set sample sizes or how ground truth for training sets was established.

    Therefore, I cannot provide the requested information based on the provided text. The document is strictly a regulatory approval notice and does not include the details of a performance study.

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