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510(k) Data Aggregation

    K Number
    K100411

    Validate with FDA (Live)

    Device Name
    VARIOUS DENTAL IMPLANTS
    Manufacturer
    GRUNDY ADVANCED BIOMEDICAL SYSTEMS LLC
    Date Cleared
    2010-07-28

    (162 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Age Range
    2 - 12
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    THE IMPLANT(S) IS DESIGNED FOR USE IN THE EDENTULOUS SITES IN THE MANDIBLE OR MAXILLA FOR SUPPORT OF A COMPLETE DENTURE PROSTHESIS, A TERMINAL OR INTERMEDIATE ABUTMENT FOR FIXED OR PARTIAL DENTURES, OR A SINGLE TOOTH REPLACEMENT. THE 8,25MM LONG IMPLANT CAN NOT BE USED AS A SINGLE TOOTH REPLACEMENT.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a dental implant. It states that the device is substantially equivalent to legally marketed predicate devices and therefore does not require a premarket approval application (PMA).

    However, this document *does not contain any information regarding:

    • Acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, accuracy)
    • Details of any specific study (clinical or analytical) that would prove the device meets acceptance criteria.
    • Sample sizes used for test sets or training sets.
    • Data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance, or types of ground truth.

    This document is a regulatory clearance and not a study report. It confirms that the device can be legally marketed based on its equivalence to existing products, but it does not provide the technical performance data that would typically be found in a study proving acceptance criteria.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor the other requested details about a study, because this information is not present in the provided text.

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