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510(k) Data Aggregation

    K Number
    K120432
    Device Name
    TELIO CS CEM IMPLANT
    Manufacturer
    IVOCLAR VIVADENT AG
    Date Cleared
    2012-06-08

    (116 days)

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

    TELIO CS CEM IMPLANT

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

    Reversible/semi-permanent cementation of long-term temporary and permanent restorations on implant abutments.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a dental cement product called "Telio® CS Cem Implant". This document is an administrative notification of clearance and does not contain any information about acceptance criteria, device performance studies, or clinical trial details as requested in the prompt.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document's purpose is to inform of the substantial equivalence determination for marketing the device, not to present a detailed technical or clinical study summary.

    The requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not present in the provided text.

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