LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K021842
    Device Name
    ADMIRA SEAL
    Manufacturer
    VOCO GMBH
    Date Cleared
    2002-07-29

    (54 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ADMIRA SEAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Sealing/filling of pits and fissures as well as small cavities
    • Sealing/facing of damaged enamel surfaces
    • Anchorage of orthodontic appliances
    • Sealing of composites or cement fillings
    • Restoration of small defects in composites and amalgam fillings
    • Sealing of deciduous teeth
    Device Description

    Not Found

    AI/ML Overview

    This FDA document is a 510(k) clearance letter for the "Admira Seal" device, a pit and fissure sealant. It does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/ML device.

    The document grants market clearance based on substantial equivalence to legally marketed predicate devices, a regulatory pathway that typically relies on demonstrating that the new device is as safe and effective as a legally marketed device that is not subject to PMA. This usually involves comparing device characteristics (e.g., materials, design, intended use) and performance data from internal testing or literature reviews, rather than clinical studies with detailed acceptance criteria and expert-adjudicated ground truth as would be expected for AI/ML performance evaluation.

    Therefore, I cannot fulfill your request for the specific details outlined (acceptance criteria, study details, sample sizes, expert qualifications, ground truth, etc.) because this information is not present in the provided text. The document simply states that the device is substantially equivalent and thus cleared for market.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1