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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
    Predicate For
    N/A
    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: < 10 µg/cm² (implied by predicate device performance and equivalence)< 10 µg/cm²
    Biocompatibility: No issuesBiocompatibility testing demonstrated no issues.
    (Additional criteria from ISO 6872:2008 not explicitly listed but performed)Fracture toughness: 1.76; CTE at 500°C: 10.1 ± 0.5 x 10-6 K-1 m/m

    2. Sample size used for the test set and the data provenance:

    • The document does not explicitly state the sample sizes used for the non-clinical tests (flexural strength, chemical solubility, fracture toughness, CTE, biocompatibility).
    • Data Provenance: The tests were performed in support of regulatory submission, likely at the manufacturer's or a contracted lab. The document does not specify the country or whether the data is retrospective or prospective, but given it's for a new product, it would be prospective testing.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • This information is not applicable. The device is a material, and "ground truth" in the context of expert consensus or pathology typically applies to diagnostic device studies. Performance is measured against established material science standards (ISO 6872:2008).

    4. Adjudication method for the test set:

    • Not applicable as explained above. Performance is based on physical and chemical testing against a standard.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • Not applicable. This is a dental material, not an AI-assisted diagnostic device.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This is a dental material, not an algorithm.

    7. The type of ground truth used:

    • Material Science Standards: The "ground truth" for the device's performance is established by recognized international standards, specifically ISO 6872:2008 for Dental ceramic. This standard defines the acceptable ranges for various physical and chemical properties.

    8. The sample size for the training set:

    • Not applicable. This is a physical material being characterized, not a machine learning model. There is no concept of a "training set" in this context.

    9. How the ground truth for the training set was established:

    • Not applicable, as there is no training set for this type of device.
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