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510(k) Data Aggregation

    K Number
    K233161
    Device Name
    BeautiLink SA
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2023-09-28

    (1 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BeautiLink SA

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

    Cementation of all-ceramic, composite and metal restorations
    Post cementation

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental cement called "BeautiLink SA." It discusses regulatory aspects, general controls, and indications for use.

    It does not contain:

    • A table of acceptance criteria and reported device performance.
    • Details about sample sizes, data provenance, or the nature of test sets (retrospective/prospective, country of origin).
    • Information on experts, ground truth establishment, or adjudication methods for any test or training sets.
    • Any mention of a Multi-Reader Multi-Case (MRMC) study or the effect size of AI assistance.
    • Details about standalone algorithm performance.
    • Information on the training set size or how its ground truth was established.

    This document is a regulatory clearance, not a study report or technical specification outlining performance metrics and supporting validation studies.

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