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510(k) Data Aggregation

    K Number
    K984198
    Device Name
    WIDE BODY ABUTMENTS
    Manufacturer
    VIDENT
    Date Cleared
    1999-02-18

    (86 days)

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

    WIDE BODY ABUTMENTS

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

    Wide Body abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments which do not osseointegrate are to be seated directly on tope of the implant body. The abutments form the substructure of the restored prosthesis.

    Device Description

    Wide Body Abutments

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for "Wide Body Abutments". This document does not contain information about acceptance criteria, device performance testing, or study details as typically found in a clinical study report or a 510(k) submission summary for an AI/ML medical device.

    The information requested in the prompt (acceptance criteria, sample size, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is specific to the evaluation of AI/ML software or diagnostic devices. The device described in this document is a physical dental implant component (Wide Body Abutments), which would be evaluated based on mechanical properties, biocompatibility, and fit, rather than AI performance metrics.

    Therefore, I cannot provide the requested information based on the given document.

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