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510(k) Data Aggregation

    K Number
    K041492
    Device Name
    ASTRA TECH IMPLANTS - DENTAL SYSTEM
    Manufacturer
    ASTRA TECH, INC.
    Date Cleared
    2004-08-09

    (66 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K022562
    Predicate For
    K043195,K061319,K073075
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Astra Tech Implants – Dental System are for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Astra Tech Implants - Dental System are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

    Device Description

    The Astra Tech Dental Implants are root-formed threaded screws made from commercially pure titanium.

    AI/ML Overview

    The provided text is a 510(k) summary for the Astra Tech Implants - Dental System, related to a labeling change for "immediate function." It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving that the device meets those criteria.

    Therefore, I cannot provide the requested information. The document appears to be a regulatory submission for a device modification (change in labeling/intended use for immediate function) rather than a report detailing a new performance study with acceptance criteria.

    Missing Information from the Provided Text:

    • Table of acceptance criteria and reported device performance: This document does not specify any performance-based acceptance criteria or report device performance against such criteria. The submission is for a labeling change allowing "immediate function," which implies clinical outcomes, but no such data is presented.
    • Sample size used for the test set and data provenance: No test set is described.
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment activity is described.
    • Adjudication method for the test set: No test set is described.
    • Multi-reader multi-case (MRMC) comparative effectiveness study: No MRMC study is mentioned.
    • Standalone (algorithm only without human-in-the-loop performance) study: No such study is mentioned.
    • Type of ground truth used: No ground truth is described.
    • Sample size for the training set: No training set is described.
    • How the ground truth for the training set was established: No training set is described.
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