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510(k) Data Aggregation

    K Number
    K972276
    Device Name
    CEREC 2 CROWN SOFTWARE
    Manufacturer
    SIEMENS AG
    Date Cleared
    1997-08-15

    (58 days)

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

    CEREC 2 CROWN SOFTWARE

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

    The Cerec 2 Crown Software is a modification of the Cerec 2 Dicor Dental Restoration System. The Cerec 2 System is used to obtain an optical impression using a threedimensional camera. The optical impression is used in the computer-aided design and milling of ceramic restorations including inlays, veneers and partial crowns. The modifications extend the capabilities to include full crowns.

    Device Description

    The Cerec 2 Crown Software is a modification of the Cerec 2 Dicor Dental Restoration System.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Cerac 2 Crown Software. It states that the device is substantially equivalent to a predicate device but does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely a regulatory clearance and does not delve into the technical validation of the device.

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