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510(k) Data Aggregation

    K Number
    K230143

    Validate with FDA (Live)

    Device Name
    DESS Dental Smart Solutions
    Manufacturer
    Terrats Medical SL
    Date Cleared
    2023-04-13

    (85 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K061319,K192221,K130572,K201553,K222269
    Predicate For
    K231434
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DESS Multi-Unit Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

    Device Description

    The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments cleared previously in K170588, K173908, K191986, K212577, K212628, K222269, and K22288. These previously cleared abutments are compatible with a variety of original equipment manufacturers (OEM) of dental implants. This submission adds abutments for implant lines from Implant Direct Sybron Manufacturing LLC (hereinafter, Implant Direct). The subject device abutments are compatible with various Implant Direct internal hex and internal conical implant bodies. The subject device abutments include Multi-Unit Abutments in straight, 17° angled, and 30° angled designs. All abutments are provided with the appropriate abutment screw (ff applicable) for attachment to the corresponding implant. All abutments and screws are provided non-sterile. The subject device is only intended for multi-unit restorations such as bridges and bars.

    AI/ML Overview

    This appears to be a 510(k) Summary for a medical device (dental abutments) rather than a study report with acceptance criteria for an AI/ML powered device. The document describes the device, its intended use, comparison to predicate devices, and non-clinical performance data (mechanical testing, biocompatibility, sterilization validation, MRI compatibility). It explicitly states: "No clinical data were included in this submission."

    Therefore, I cannot extract acceptance criteria or information about a study that proves the device meets those criteria in the context of an AI/ML device, as the provided text doesn't describe such a device or study.

    If the request was based on a misunderstanding of the document's content, please clarify. If you're looking for general information on what would be included in such a study for an AI/ML device, I can provide a theoretical outline.

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