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510(k) Data Aggregation

    K Number
    K172240
    Device Name
    SPI Dental Implant System
    Manufacturer
    MSI France
    Date Cleared
    2018-01-31

    (189 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K112795,K162299
    Why did this record match?
    Device Name :

    SPI Dental Implant System

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

    The SPI Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

    It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

    Device Description

    SPI Dental Implant System is an internal hex implant system which comes in 3.3, 3.7, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13 and 16. Both straight and angled abutments are available.

    The implant is a conical shape one with a grit blasted and acid etched surface. Standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multiunit abutments, ball attachments, healing caps and standard 15° and 25° abutments are included in the system.

    AI/ML Overview

    This is an FDA 510(k) summary for a medical device (SPI Dental Implant System), not a study report for an AI/ML powered device. As such, it does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning AI/ML performance.

    The document describes standard engineering and biocompatibility testing for a dental implant, confirming its substantial equivalence to a predicate device. It includes:

    • Testing Summary:
      • Dynamic fatigue testing according to ISO 14801
      • Surface analysis (SEM and EDS)
      • Sterilization according to ISO 11137-1 and 11137-2 (implants), ISO 17665-1 and ISO 17665-2 (abutments)
      • Package integrity testing according to ASTM F1929-12
      • Accelerated aging according to ASTM F1980-07
      • Material compliance with ASTM F136
      • Biocompatibility (cytotoxicity) according to ISO 10993-5
      • Endotoxin testing according to USP 161

    These tests are designed to demonstrate the physical, chemical, and biological safety and performance of the dental implant itself, not the performance of an AI/ML algorithm.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies because the provided document does not pertain to an AI/ML device.

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