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    K Number
    K120053
    Device Name
    IPS E.MAX PRESS - ABUTMENT SOLUTIONS
    Manufacturer
    IVOCLAR VIVADENT AG
    Date Cleared
    2012-10-18

    (286 days)

    Product Code
    NHA,EIH
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K062129,K072071
    Why did this record match?
    Device Name :

    IPS E.MAX PRESS - ABUTMENT SOLUTIONS

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

    IPS e.max® Press Abutment Solutions is intended for use in partially or fully endentuous mandibles and maxillae in support of single or multiple-unit cement retained . restorations.

    IPS e.max Press Abutment Solutions is recommended for the fabrication of:

    • Hybrid abutments for single-tooth restorations •
    • Hybrid abutment crowns for restorations -
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental device, "IPS e.max® Press - Abutment Solutions." This document primarily addresses regulatory approval based on substantial equivalence to predicate devices and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies as typically found in a clinical study report or technical performance verification document.

    Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them from this document.

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