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510(k) Data Aggregation

    K Number
    K053355
    Device Name
    BTI INTERNA DENTAL IMPLANT SYSTEM
    Manufacturer
    B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.
    Date Cleared
    2006-03-14

    (102 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K022258
    Predicate For
    K061383,K070533,K090081,K091387,K092112,K211952
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Dental implant system comprising endosseous titanium implants and prosthetic elements to be attached to the implants, as well as auxiliary elements for surgical and prosthetic procedures.

    The intended use of the system is the restoration of missing teeth in partially or fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.

    Device Description

    The BTI Interna Dental Implant System is designed to server as support for prosthetic devices to restore chewing function. The implants have a surgical diameter range of from 3.3 to 4.0 mm for the universal platform implant. 4.0 for Universal Plus Platform and 4.5 to 5.0 mm for wide platform. Lengths range from 7,0 to 18,0 mm.

    AI/ML Overview

    This document is a 510(k) summary for the BTI Interna Dental Implant System, seeking to establish substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through testing.

    Therefore, I cannot provide the requested information. The document focuses on regulatory submission and asserting substantial equivalence, not on detailed performance studies with acceptance criteria.

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