LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K102804
    Device Name
    SPI TITANIUM BASE FOR CAD/CAM
    Manufacturer
    THOMMEN MEDICAL, AG
    Date Cleared
    2011-04-20

    (205 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K031747,K083496,K073553,K040170,K032263,K083297
    Why did this record match?
    Device Name :

    SPI TITANIUM BASE FOR CAD/CAM

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

    Thommen Titanium Base for CAD/CAM abutments are intended to be used in conjunction with Thommen implants and the 3M ESPE Lava™ System in the maxillary and/or mandibular arch to provide support for crowns and bridges.

    Device Description

    Titanium Base for CAD/CAM provides a foundation for a customized CAD/CAM abutments and restorations. It is suitable for precision fit custom abutments or crown and bridge restorations fabricated with CAD/CAM technology provided separately by 3M ESPE as the Lava System. The Titanium Base for CAD/CAM in conjunction with the 3M ESPE Lava System is not intended to be used to fabricate angled abutments. Titanium Base for CAD/CAM is made from commercially pure titanium, grade 4 conforming to ASTM F67, and the corresponding abutment screw (cleared under K031747) is made of titanium alloy, Ti-6Al-7Nb conforming to ASTM F1295.

    AI/ML Overview

    The provided text is a 510(k) Summary for a medical device called "SPI® Titanium Base for CAD/CAM". This document aims to demonstrate substantial equivalence to legally marketed predicate devices, not to present a study proving the device meets specific acceptance criteria in the manner one might describe for a diagnostic or AI-driven device.

    Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set size) are not applicable to this type of regulatory submission.

    The "acceptance criteria" in this context refer to the demonstration of "substantial equivalence" to predicate devices based on design, materials, intended use, and operating principles, rather than performance metrics from a formal clinical or technical study against predefined thresholds.

    Here's a breakdown based on the information provided and what is not applicable:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Demonstration of Substantial Equivalence)Reported Device Performance (Characteristics)
    Same intended use as predicate devicesIntended for use in conjunction with Thommen implants and the 3M ESPE Lava™ System in the maxillary and/or mandibular arch to provide support for crowns and bridges.
    Same operating principle as predicate devicesFunctions as a foundation for customized CAD/CAM abutments and restorations.
    Same basic design as predicate devicesConsists of a titanium base/post used in CAD/CAM fabrication of custom dental implant abutments/restorations and an abutment screw.
    Same or very similar materials as predicate devicesMade from commercially pure titanium, grade 4 (ASTM F67) for the base, and titanium alloy, Ti-6Al-7Nb (ASTM F1295) for the abutment screw. Predicate devices also use commercially pure titanium or titanium alloy.
    Similar packaging and sterilization methods as predicate devicesPackaged in similar materials and sterilized using similar methods as predicate devices.
    Encompass the same range of physical dimensions/configurationEncompasses the same range of physical dimensions, including sizes and configuration as predicate devices.
    Differences in technological characteristics do not raise new issues of safety or efficacyNot explicitly detailed, but implied by the overall claim of substantial equivalence with no new issues of safety or efficacy.

    2. Sample size used for the test set and the data provenance

    • Not Applicable. This submission is for a dental abutment demonstrating substantial equivalence to predicate devices, not a diagnostic or AI device requiring a test set of data. The "study" here refers to the comparison of the device's characteristics against those of already cleared devices.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Not Applicable. See point 2.

    4. Adjudication method for the test set

    • Not Applicable. See point 2.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • Not Applicable. This is a hardware device (dental abutment), not an AI-driven or diagnostic system.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not Applicable. This is a hardware device, not an algorithm.

    7. The type of ground truth used

    • Not Applicable in the traditional sense of a diagnostic study. The "ground truth" for this submission is established by the known characteristics and regulatory clearance of the predicate devices. The new device's characteristics are compared against these established devices.

    8. The sample size for the training set

    • Not Applicable. No training set is used for this type of submission.

    9. How the ground truth for the training set was established

    • Not Applicable. See point 8.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1