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510(k) Data Aggregation

    K Number
    K974628
    Device Name
    FRIALIT-2 PROTECT ABUTMENT
    Manufacturer
    FRIATEC AG
    Date Cleared
    1998-03-11

    (90 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FRIALIT-2 PROTECT ABUTMENT

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

    The FRIALIT-2 ProTect Abutment is intended for use as a temporary abutment system for short and longer term provisionilization of the FRIALIT-2 implant system, and a provisional abutment for screw. retained crowns or bridges.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the FRIALIT-2 ProTect Abutment. This type of document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    The 510(k) clearance process is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than rigorous performance testing and clinical trials that would be described by the questions you've posed. The letter confirms that the device is substantially equivalent for its stated indications for use (as a temporary abutment system for provisionalization of the FRIALIT-2 implant system, and a provisional abutment for screw-retained crowns or bridges).

    Therefore, I cannot answer any of your questions based on the provided text. The requested information is not present in this regulatory document.

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