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510(k) Data Aggregation

    K Number
    K151490
    Device Name
    PRETTAU ANTERIOR T0
    Manufacturer
    ZIRKONZAHN GMBH
    Date Cleared
    2015-10-08

    (127 days)

    Product Code
    EIH,PAN
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K132230
    Why did this record match?
    Device Name :

    PRETTAU ANTERIOR T0

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

    PRETTAU® ANTERIOR T0 is intended to be used for the manufacturing of metal free single-unit anterior and posterior prostheses, inlays, onlays, veneers bonded dental restorations.

    Device Description

    PRETTAU® ANTERIOR T0 is a millable dental ceramic material made of zirconia.

    PRETTAU® ANTERIOR TO is destined for manufacture with CAD/CAM technology of metal free single-unit anterior and posterior prostheses, implant superstructures, inlays, onlays and veneers as fully anatomical restoration as well as for reduced structures for veneering with ceramics. The device is compatible with commercially available dental CAD/CAM systems must be validated by the user. The blocks are suitable for all milling units which are able to process presintered zirconia and which have the proper clamping device for the corresponding blank. PRETTAU® ANTERIOR TO is marketed in 25 different outer shapes, i.e. barrel, discs, rectangular, and special shapes; the blocks are produced in various heights from 10mm to 50 mm for each shape.

    AI/ML Overview

    This document is a 510(k) Summary for the medical device PRETTAU® ANTERIOR T0, a millable dental ceramic material made of zirconia. It provides information about the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

    Here's an analysis to extract the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (from ISO 6872:2008 for Type II Class a&b and 2a esthetic dental ceramic)Reported Device Performance (PRETTAU® ANTERIOR T0)
    Flexural Strength: ≥ 600 Mpa (implied by statement that 600 Mpa is "well above the limits")600 Mpa
    Chemical Solubility:
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