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510(k) Data Aggregation

    K Number
    K073368
    Device Name
    5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT
    Manufacturer
    BICON, LLC
    Date Cleared
    2008-10-10

    (315 days)

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

    5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT

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

    The 5.0 x 5.0mm and the 6.0 x 5.0mm implants are designed as a one stage or two stage surgical procedure implant for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework, partial dentures, or a single tooth replacement

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter for a dental implant system. It discusses the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

    However, the text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as would be expected for an AI/ML device study. This document is a regulatory approval notice for a physical medical device, not a report on the performance of a software or algorithm.

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