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510(k) Data Aggregation

    K Number
    K062515
    Device Name
    RETENTION FLOW OPAQUE
    Manufacturer
    HERAEUS KULZER GMBH
    Date Cleared
    2006-11-22

    (86 days)

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

    RETENTION FLOW OPAQUE

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

    Retention Flow Opaque is a light curing, transparent component for filling undercut areas in retentions.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot provide the requested information. The document is an FDA 510(k) clearance letter for a dental device called "Retention Flow Opaque." It confirms the device's substantial equivalence to a predicate device but does not contain any details about:

    • Acceptance criteria or reported device performance metrics.
    • Specific studies (e.g., test set sample size, data provenance).
    • Ground truth establishment details (number of experts, qualifications, adjudication method, type of ground truth).
    • Whether MRMC or standalone performance studies were conducted, or any associated effect sizes.
    • Training set details (sample size or ground truth establishment).

    The letter primarily focuses on regulatory approval and compliance.

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