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510(k) Data Aggregation

    K Number
    K131345
    Device Name
    TIARRAY DENTAL IMPLANT SYSTEM
    Manufacturer
    NASSEO, INC.
    Date Cleared
    2013-08-07

    (90 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K061003,K071370,K061319
    Why did this record match?
    Device Name :

    TIARRAY DENTAL IMPLANT SYSTEM

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

    The TiArray Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

    Device Description

    TiArray Dental Implant System implants included in this submission are endosseous dental implants with an internal hex implant/abutment interface. They are designed to provide support for prosthetic teeth to restore chewing function. The implants are made of commercially pure titanium, with a surface that is etched and anodized. Implants are provided in a tapered, threaded design with micro-grooves around the neck of the implant and two cutting flutes. Straight abutments made of titanium alloy are provided for each diameter implant for cement-retained prostheses. The implant is available in three diameters (3.5, 4.3, and 5.0 mm), each in four lengths (8.0, 10.0, 11.5, and 13.0). The abutments come in three platform diameters (3.5, 4.3, and 5.0 mm) that correspond to the diameters of the implant.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study demonstrating that the device meets such criteria.

    The 510(k) summary for the TiArray Dental Implant System (K131345) states:

    • "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility, engineering analysis and dimensional analysis."
    • "Clinical data were not submitted in this premarket notification."

    Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and type of ground truth cannot be extracted from this document. The submission relies on non-clinical data to demonstrate substantial equivalence to predicate devices, rather than a study against specific acceptance criteria.

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