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510(k) Data Aggregation

    K Number
    K050393
    Device Name
    THE GUIDED SURGERY CONCEPT
    Manufacturer
    NOBEL BIOCARE AB
    Date Cleared
    2005-05-04

    (77 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K030685
    Predicate For
    K053602,K112679,K113739,K123976
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Guided Surgery Concept and Teeth-in-an-Hour are indicated for the treatment of single, partially and totally edentulous jaws for placement of implant fixtures with immediate function to restore patient esthetics and chewing function. The following prerequisites must be fulfilled:

    • adequate amount of jaw bone
    • the quality of jaw bone must be judged as adequate
    Device Description

    The Guided Surgery Concept is intended for the treatment of totally and partially edentulous jaws as well as single unit cases. The Guided Surgery Concept enables a predictable, fast and minimally invasive endosseous dental implant installation procedure according to case planning done by the clinician.

    The Guided Surgery Concept enables the final prosthesis to be produced prior to and attached in the same session as the implant installation. The entire procedure is typically completed within one hour and can be used for the treatment of totally and partial edentulous patients as well as patients missing a single tooth.

    The Guided Surgery Concept includes 3D Planning Software that enables the clinician to view threedimensional CT-scan data as well as to plan the case in a virtual three-dimensional environment. This case planning can be used to produce a Surgical Template, thus transferring the virtual case planning into physical tools enabling the surgical installation according to the virtual case planning.

    The Guided Surgery Concept is based upon knowledge of the location and orientation of the implant(s) prior to the surgery. This knowledge enables the production of a Surgical Template. Aided by the Surgical Template, the sites can be prepared and the implants placed in the predetermined locations enabling the immediate attachment of the prefabricated temporary or final prosthesis.

    AI/ML Overview

    This document does not contain information regarding detailed acceptance criteria, the study that proves the device meets the acceptance criteria, or any details about device performance or testing. The document is primarily a 510(k) summary and FDA approval letter for a dental implant system.

    Therefore, I cannot provide the requested information based on the given text.

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