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510(k) Data Aggregation

    K Number
    K211804
    Device Name
    3Delta Crown
    Manufacturer
    DeltaMed GmbH
    Date Cleared
    2021-12-06

    (178 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    3Delta Crown

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

    Additive production of permanent anterior and posterior restorations, e.g. - Single-tooth crowns - Veneers, inlays, onlays

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria for a device, a study that proves the device meets acceptance criteria, or any details about device performance metrics, sample sizes, expert qualifications, or ground truth establishment.

    The document is an FDA 510(k) clearance letter for a device called "3Delta Crown," manufactured by DeltaMed GmbH. It informs the company that their device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. The "Indications for Use" section lists the intended applications of the 3Delta Crown (additive production of permanent anterior and posterior restorations, such as single-tooth crowns, veneers, inlays, and onlays).

    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.

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