LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K012496
    Device Name
    CARBON POST
    Manufacturer
    J. MORITA USA, INC.
    Date Cleared
    2002-05-17

    (287 days)

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

    CARBON POST

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

    The Carbon Post is a root canal post for use with composite resin cement in a prepared root canal in a non-vital tooth to stabilize and support a restoration.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification FDA letter for a device called "Carbon Post." This document is a regulatory approval letter and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the input text. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed, but it does not detail the scientific studies or performance data that would typically be associated with such a submission.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1