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510(k) Data Aggregation

    K Number
    K972889
    Device Name
    ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION)
    Manufacturer
    W & H DENTALWERK
    Date Cleared
    1998-01-22

    (170 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Indications are very widespread in the field of oral surgery ranging from

    • A. Implant placement, including
        1. preparation of the osteotomy site
        1. bone recontouring, osteoplasty
    • B. Bone grafting
        1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
        1. harvesting autogen living bone
        1. sinus elevation & grafting of alveolar sockets
    • C. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions
    • D. Periodontal surgeries
        1. bone recontouring & alveoplasty around living teeth
        1. removal of exostosis
    • E. Endodontic treatment Intracanal preparations using rotating NiTi-files.
    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the ELCOmed 100 and ELCOmed 200 devices. It states that the devices are substantially equivalent to previously marketed devices. However, this letter does not contain any specifics regarding acceptance criteria, device performance, or details of a study that proves the device meets such criteria.

    The information provided only includes:

    • Device Name: ELCOmed 100 and 200
    • 510(k) Number: K972889
    • Indications for Use: A list of oral surgery-related procedures the device is intended for.
    • Regulatory Class: I
    • Product Code: EBW

    Therefore, I cannot provide the requested information. The document does not describe:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set or its data provenance.
    3. Number of experts or their qualifications for ground truth establishment.
    4. Adjudication method for the test set.
    5. MRMC comparative effectiveness study or its effect size.
    6. Standalone performance study for the algorithm.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    To obtain this information, one would typically need to refer to the full 510(k) submission, which would contain detailed validation studies and performance data.

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