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510(k) Data Aggregation

    K Number
    K022971
    Device Name
    MICROHYBRID 11
    Manufacturer
    AB ARDENT
    Date Cleared
    2002-11-25

    (80 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MICROHYBRID 11 is to be used as a filling material for restoring function to teeth that have lost portions due to caries:

    Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV

    Class V restorations, cervical caries, root erosion, wedge shaped defects.

    Posterior restorations, Class I, II.

    Splinting of mobile teeth.

    Preventive restorations in molars and premolars.

    Repair of composite and ceramic veneers.

    Inlays/onlays with extra-oral post tempering

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) premarket notification letter for a dental device called "Microhybrid 11," primarily focusing on its substantial equivalence determination. It lacks details about performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

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