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510(k) Data Aggregation

    K Number
    K121621
    Device Name
    SOLOCEM
    Manufacturer
    COLTENE/WHALEDENT AG
    Date Cleared
    2013-01-08

    (221 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SOLOCEM

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

    SoloCem is indicated for

    • permanent cementation of root posts of all types
    • permanent cementation of crowns, bridges, inlays, onlays
    • permanent cementation of implant abutments
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification approval letter from the FDA for a dental cement called SoloCem. This document focuses on the regulatory approval process and does not contain detailed information about specific acceptance criteria for a device's performance, nor does it describe a study proving the device meets particular criteria.

    Therefore, I cannot extract the requested information such as a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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