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510(k) Data Aggregation

    K Number
    K230523
    Device Name
    s-Clean Link Abutment Narrow
    Manufacturer
    Dentis Co., Ltd.
    Date Cleared
    2023-05-24

    (86 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K161244,K222913
    Why did this record match?
    Device Name :

    s-Clean Link Abutment Narrow

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

    s-Clean Link Abutment Narrow is intended for use with dental implant as a support for single or multiple tooth prostheses in mandibular central and lateral incisors and maxillary lateral incisors.

    s-Clean Link Abutment Narrow is intended for use with the s-Clean OneQ-SL Narrow Fixture according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment Narrow are intended to be manufactured at a Dentis validated milling center.

    Device Description

    The s-Clean Link Abutment Narrow is intended to provide support for customized prosthetic restorations such as crowns and bridges. The s-Clean Link Abutment is composed of a two-piece abutment that is a link abutment at the bottom and a coping (CAD/CAM patient specific superstructure) as the top-half. The submission also includes an abutment fixation screw. The s-Clean Link Abutment are pre-manufactured (stock) abutments, made from a titanium alloy conforming to ASTM F136.

    The top half of the s-Clean link abutment composed of zirconia is referenced from our previously cleared K222913 submission.

    s-Clean Abutment Screw is made of Ti-6Al-4V ELI (ASTM F136) and cleared in K161244.

    The diameters of s-Clean Link Abutment Narrow are 4.0 and 4.5mm.

    s-Clean Link Abutment Narrow is provided non-sterile and must be sterilized after the cementation of the patientspecific superstructure on the Link Abutment Narrow.

    AI/ML Overview

    Accessing the provided text, there is no information about an AI/ML device, its acceptance criteria, or a study proving that it meets those criteria. The document describes a traditional medical device, specifically a dental implant abutment (s-Clean Link Abutment Narrow), and its 510(k) clearance process.

    Therefore, I cannot provide the requested information. The text does not contain details regarding:

    1. A table of acceptance criteria and reported device performance for an AI/ML device.
    2. Sample sizes or data provenance for an AI/ML test set.
    3. The number or qualifications of experts for establishing ground truth for an AI/ML device.
    4. Adjudication methods for an AI/ML test set.
    5. A multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
    6. Stand-alone performance of an AI algorithm.
    7. The type of ground truth used for an AI/ML device.
    8. The sample size for an AI/ML training set.
    9. How ground truth for an AI/ML training set was established.

    The document focuses on non-clinical testing for equivalence to a predicate device, material testing, sterilization validation, biocompatibility, and MRI compatibility for a physical dental implant component.

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