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510(k) Data Aggregation

    K Number
    K972417
    Device Name
    THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM
    Manufacturer
    BICON, INC.
    Date Cleared
    1997-09-17

    (82 days)

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

    THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM

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

    The 6.0 x 8.0mm implant is designed 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

    6.0 x 8.0mm Dental Implant System

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental implant system. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot provide the requested information based on this document.

    The document primarily focuses on:

    • Confirming that the device is "substantially equivalent" to legally marketed predicate devices.
    • Outlining the regulatory classification and general controls applicable to the device.
    • Providing contact information for various FDA offices.
    • Specifying the "Indications For Use" for the 6.0 x 8.0mm Dental Implant System.

    There is no mention of clinical studies, performance metrics, ground truth establishment, or sample sizes related to testing and validation in this regulatory clearance letter.

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