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510(k) Data Aggregation

    K Number
    K080130
    Device Name
    OCCLUFAST CAD
    Manufacturer
    ZHERMACK S.P.A.
    Date Cleared
    2008-03-14

    (56 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OCCLUFAST CAD

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

    Zhermack OCCLUFAST CAD is a dental impression material intended to be placed on a dental patient's teeth for bite registration to reproduce the structure of a patient's teeth to provide models for study or for production of restorative prosthetic devices.

    Occlufast CAD has been developed for use with CAD/CAM systems.

    Device Description

    dental impression material

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a dental impression material named Occlufast® CAD. This type of document primarily confirms that a new device is "substantially equivalent" to a predicate device already on the market, based on its indications for use and sometimes on performance data.

    However, the letter does not contain any information regarding specific acceptance criteria for device performance, nor details of a study that proves the device meets such criteria. It's a regulatory clearance, not a technical performance report.

    Therefore, I cannot provide the requested information from the given text. The document does not describe:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for any test sets.
    3. Number or qualifications of experts used for ground truth.
    4. Adjudication methods.
    5. MRMC comparative effectiveness studies.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    The document states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination typically relies on comparing the new device's technological characteristics and intended use to those of a predicate device, sometimes supported by basic performance testing to ensure safety and effectiveness are comparable, but detailed study reports and acceptance criteria are not typically included in the publicly available clearance letter itself.

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