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510(k) Data Aggregation

    K Number
    K052820
    Device Name
    PARAPOST PARACORE AUTOMIX 5ML
    Manufacturer
    COLTENE/WHALEDENT AG
    Date Cleared
    2006-01-09

    (97 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PARAPOST PARACORE AUTOMIX 5ML

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

    ParaPost ParaCore automix 5ml is indicated for core build-ups and cementation of posts

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Coltene/Whaledent AG regarding their device, ParaPost ParaCore Automix 5ml. This document primarily focuses on the FDA's determination of substantial equivalence to a predicate device and provides regulatory guidance.

    It does not contain any information about acceptance criteria for device performance, study details, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based on the provided text.

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