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510(k) Data Aggregation

    K Number
    K200597
    Device Name
    Straumann BLX Gold Abutments
    Manufacturer
    Straumann USA, LLC (On behalf of Institut Straumann AG)
    Date Cleared
    2020-08-19

    (163 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K072497,K071888,K190662,K173961,K070549
    Why did this record match?
    Device Name :

    Straumann BLX Gold Abutments

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

    Straumann abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges, and overdentures.

    Device Description

    The Straumann prosthetic line consist of abutments which are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. They are available in a variety of shapes and sizes to fit individual patient needs.

    The Straumann BLX Gold Abutments consist of a Ceramicor® alloy base, which is fixed to the implant by mean of a basal screw made of Ti-6AI-7Nb, Titanium Aluminum Niobium (TAN). The screw channel is protected during the lab procedure with a modeling aid made of Polyoxymethylene (POM) which is friction fit to the Ceramicor® alloy base. The modeling aid is a burn-out sleeve for casting and the combination of base and modeling aid is designed to be used together with Straumann BLX Implants having the TorcFit™, conical connection.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (Straumann® BLX Gold Abutments) and does not describe an AI medical device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria, study details for AI performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for an AI system.

    The document focuses on demonstrating substantial equivalence to predicate devices through material comparison, biocompatibility, sterilization validation, and bench testing for mechanical properties (dynamic fatigue, static strength, and loosening torque).

    Here's an overview of the "acceptance criteria" and "study" information that is present, pertaining to a traditional medical device, not an AI one:

    Acceptance Criteria and Reported Device Performance (as relevant for a traditional medical device)

    Acceptance Criteria CategoryReported Device Performance (or demonstration method)
    BiocompatibilityAssessed according to ISO 10993-1:2009 and FDA Guidance. Stated to be equivalent to primary predicate (K070549) due to same material, nature of body contact, contact duration, material formulation, and sterilization methods. No new testing performed.
    SterilizationRecommended end-user sterilization (Moist Heat Steam) validated according to ISO 17665-1, ISO 17665-2, and FDA guidance "Reprocessing Medical Devices in Health Care Settings". Provided non-sterile.
    Bench Testing (Dynamic Fatigue, Static Strength, Loosening Torque)Conducted according to FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Testing performed on a worst-case construct. Results demonstrated equivalence to predicate devices.

    Missing Information (as it pertains to an AI medical device, which this is not):

    1. Sample sizes for test set and data provenance: No test set as described for an AI model.
    2. Number of experts and qualifications to establish ground truth: Not applicable for this type of device.
    3. Adjudication method for the test set: Not applicable.
    4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
    5. Stand-alone (algorithm only) performance study: Not applicable.
    6. Type of ground truth used: Not applicable.
    7. Sample size for training set: Not applicable.
    8. How ground truth for training set was established: Not applicable.
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