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510(k) Data Aggregation

    K Number
    K081666

    Validate with FDA (Live)

    Device Name
    ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS
    Manufacturer
    ASTRA TECH, INC.
    Date Cleared
    2008-10-07

    (116 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K070833,K080396
    Predicate For
    K100152,K100993,K111421
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Atlantis Abutment is intended for use with 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 prosthesis, in the maxillary lateral incisors and mandibular lateral and central incisors. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

    This device is compatible with the Astra Tech OsseoSpeed 3.0 mm Implant.

    Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

    Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

    Device Description

    The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.

    The Atlantis™ Abutments for Astra Tech OsseoSpeed 3.0 Implant System and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Astra's 3.0 mm OsseoSpeed™ Implants.

    AI/ML Overview

    This document is a 510(k) summary for the Atlantis™ Abutment for Astra Tech OsseoSpeed 3.0 Implant System and does not contain information about the acceptance criteria or a study proving that the device meets such criteria. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.

    The document states:

    • "The Atlantis™ Abutments for Astra OsseoSpeed 3.0 Implants are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments tor Astra Implants cleared under K070833 and for the Astra Tech OsseoSpeed TM Narrow Implants cleared under K080396."

    To answer the user's request, I would need a different type of document, such as a full study report or a design verification document, which is not provided here.

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