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510(k) Data Aggregation

    K Number
    K981858
    Device Name
    ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW
    Manufacturer
    ATLANTIS COMPONENTS, INC.
    Date Cleared
    1999-03-22

    (299 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K931468,K944069
    Why did this record match?
    Reference Devices :

    K931468, K944069

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

    The Atlantis abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The impression coping is intended to transfer the position of the implant in the oral cavity to a working cast. The impression coping screw is intended to temporarily secure the impression coping to either the implant fixture or the analog fixture.
    The Atlantis Abutment is used to connect an implanted fixture to a restoration.

    Device Description

    The Atlantis abutment is an abutment used with an endosseous implant that is implanted in the upper or lower jawbone. The abutment sits on the implant interface and is retained by the Atlantis screw. The abutment allows the option for the prostheses to be cemented directly to the abutment, or to be retained by a screw. The abutment is ordered by prescription from a Dentist, then is designed and manufactured by Atlantis to that prescription.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for the Atlantis Abutment System, which focuses on:

    • Identification of the device: Description, intended use, classification.
    • Comparison to a predicate device: Stating that the technological characteristics are "identical" to a previously cleared device.
    • FDA clearance letter: Confirming substantial equivalence based on the provided information.

    There is no mention of specific performance metrics, acceptance criteria, study design, sample sizes, ground truth establishment, or any results from a performance study. This is typical for a 510(k) submission where substantial equivalence to a predicate device is claimed, often without needing to conduct new performance studies if the technological characteristics are deemed identical and safety/effectiveness are established through the predicate.

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