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510(k) Data Aggregation

    K Number
    K042848
    Device Name
    FRC POSTEC PLUS
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2004-11-22

    (38 days)

    Product Code
    ELR
    Regulation Number
    872.3810
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FRC POSTEC PLUS

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

    Intended for use by dentists to give retention for reconstruction of endontically treated teeth.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a dental device (FRC Postec Plus) and primarily focuses on regulatory approval based on substantial equivalence to a predicate device. It does not detail specific performance acceptance criteria or the study design and results as requested in your prompt.

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