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    K Number
    K230877
    Device Name
    Admira Fusion 5
    Manufacturer
    VOCO GmbH
    Date Cleared
    2023-07-13

    (105 days)

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

    Admira Fusion 5

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Class I to V restorations
    • Base in class I and II cavities
    • Reconstruction of traumatically damaged anteriors
    • Facetting of discoloured anteriors
    • Correction of shape and shade for improved aesthetic appearance
    • Locking, splinting of loose teeth
    • Repairing veneers, small enamel defects and temporary C&B-materials
    • Extended fissure sealing
    • Restoration of deciduous teeth
    • Core build-up
    • Composite inlays
    Device Description

    Not Found

    AI/ML Overview

    This is an FDA clearance letter for a dental material (Admira Fusion 5), not a medical device that uses AI or requires a study with specific acceptance criteria related to algorithm performance. Therefore, the provided text does not contain the information needed to answer the questions about acceptance criteria, study design, ground truth, or expert involvement as described in your prompt.

    The document is a 510(k) premarket notification clearance letter, which confirms that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements for dental materials.

    To answer your questions, I would need a document that describes the clinical performance or validation study of a specific medical device, especially one involving an AI algorithm.

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