LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K960639
    Device Name
    ABUTMENT SELECTION KIT
    Manufacturer
    NOBELPHARMA USA, INC.
    Date Cleared
    1996-05-14

    (90 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K944963
    Why did this record match?
    Device Name :

    ABUTMENT SELECTION KIT

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

    The Nobelpharma BRANEMARK SYSTEM® Abutment Selection Kit is intended to be used by practitioners to select the proper abutment.

    Device Description

    The Nobelpharma BRANEMARK SYSTEM® Abutment Selection Kit consists of trial models of various abutments which are used by the practitioner to select the proper abutment. It can be used in two situations: in a patient's mouth and/or on a plaster model. The abutment selection system is used in a patient's mouth for only 5-10 minutes so that the clinician can determine the proper abutment type and length.

    AI/ML Overview

    This document is a 510(k) summary for a medical device called the "BRANEMARK SYSTEM® Abutment Selection Kit." It's a pre-market notification from 1996.

    Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document primarily focuses on:

    • Device Identification: Name, address, contact person, product name.
    • Predicate Device: K944963 (another abutment selection kit).
    • Device Description: Trial models of abutments for selection, used in a patient's mouth for 5-10 minutes or on a plaster model.
    • Intended Use: To select the proper abutment.
    • Comparison of Technological Characteristics: Stating that the characteristics are "identical" to the predicate, with the only notable difference being a "proposed colorant method... to provide a bright color distinction between the 'trial' abutments and the abutments intended for long-term use."

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or MRMC studies because this document does not contain that type of data.

    This document is a regulatory submission for a simple, non-active, non-diagnostic device (trial models for fitting) that is being compared to a substantially equivalent predicate. The type of rigorous performance studies and detailed acceptance criteria typically associated with AI/diagnostic devices (which your questions are geared towards) are not relevant or present in this context.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1