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510(k) Data Aggregation

    K Number
    K192029
    Device Name
    Straumann PUREloc abutments
    Manufacturer
    Institut Straumann AG
    Date Cleared
    2019-10-28

    (90 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K180477,K190662,K190040
    Why did this record match?
    Device Name :

    Straumann PUREloc abutments

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

    The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann implants.

    Device Description

    The Straumann® Retentive System (to which PUREloc belongs) is designed for the use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. The Straumann® Retentive System consists of abutments which are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. They are available in different sizes and angles to fit individual patient needs. Straumann® PUREloc abutments are used exclusively on the Straumann PURE Ceramic Implants, are available in 6 heights (1 mm, 2 mm, 3 mm, 4 mm, 5 mm, and 6 mm) and made of Yttrium-stabilized zirconia ceramic (ISO 13356 - Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)). The Straumann® PUREloc abutments are non-engaging and the implant-to-abutment connection is provided for by the basal screw. The basal screw is manufactured from Titanium Grade 4 and is identical to the basal screw cleared under K180477.

    AI/ML Overview

    This is a 510(k) premarket notification for the Straumann® PUREloc abutments. It describes the device, its intended use, and compares its technological characteristics to predicate and reference devices. However, this document does not contain acceptance criteria for an AI/ML device or a study demonstrating the device meets such criteria.

    The information provided in this document pertains to traditional medical device clearance, focusing on:

    • Substantial Equivalence: Comparing the proposed device to legally marketed predicate devices.
    • Performance Testing: Bench testing (dynamic fatigue, snapping force, dynamic force), sterilization validation, and biocompatibility evaluations.

    Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, ground truth details, MRMC study, or standalone algorithm performance) related to an AI/ML device from this document. The document describes criteria for dental implant abutments, not an AI/ML system.

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